Tag: United States

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STAT+: Revolution Medicines starts shipping experimental pancreatic cancer drug

CHICAGO — The biotech company Revolution Medicines has begun sending its experimental, life-extending treatment for pancreatic cancer to physicians and their patients under an early access program authorized by the Food and Drug Administration, the company’s CEO, Mark Goldsmith, told STAT.

“We are now shipping the drug,” he said, speaking Friday evening at a STAT event held in conjunction with the annual meeting of the American Society of Clinical Oncology. 

The drug, daraxonrasib, is not yet approved. But patients with pancreatic cancer have been clamoring for it since mid-April, when Revolution reported the striking results of a Phase 3 clinical trial. Patients treated with daraxonrasib lived nearly twice as long as patients offered standard chemotherapy — an outcome unprecedented in the pancreatic cancer field. 

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STAT+: As Ebola outbreak grows, Trump administration veers from previous government playbook

WASHINGTON — In January 2025, with the Covid-19 pandemic still top of mind, the Biden administration left behind extensive plans for how the federal bureaucracy should work to stop future disease outbreaks.

The plans were hundreds of pages long and addressed dozens of specific issues, including the government response to diseases like Ebola and how to move Americans from outbreak zones back to the U.S. for care.

But weeks later, the Trump administration took Washington by storm — and began disregarding the plans, according to two former Centers for Disease Control and Prevention officials who worked in the Trump administration and four people familiar with the Biden-era plans.

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STAT+: At ASCO, positive data for Bristol in multiple myeloma and Pfizer in lung cancer

You’re reading the web edition of ASCO in 30 Seconds, STAT’s guide to the American Society of Clinical Oncology annual meeting. Sign up for email editions here.  

We’re ASCOmaxxing.

Rest assured, this will not require Adam Feuerstein, Matthew Herper or Angus Chen to hammer on their jawlines. They will, however, be scouring the ASCO annual meeting to bring you the cancer news, analysis and event coverage you crave.

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Pfizer, Innovent Ink Up-to-$10.5B+ Cancer Treatment Collaboration

Pfizer and Innovent Biologics will partner to research and develop 12 early-stage and de novo antibodies and antibody-drug conjugates (ADCs) designed to treat various cancers, the companies said today, through a collaboration that could generate up to $10.5 billion for the Chinese biotech.

The companies said they have signed a strategic global licensing and collaboration agreement that includes licensing, co-development, and co-commercialization deals for both the ADCs, which would be created with payloads that differentiate them from other conjugates, as well as multi-specific antibodies, to be developed with unique designs and differentiated immune-engaging features.

Pfizer and Innovent plan to work across a portfolio of 12 programs—eight early-stage programs originating with Innovent, and four Pfizer discovery programs. The companies said they will co-develop and share costs for selected programs as they advance them through clinical development.

The collaboration is intended to marry Pfizer’s global scientific, clinical development, regulatory, and commercial scale capabilities with Innovent’s scientific discovery and clinical capabilities in oncology.

“By combining Innovent’s discovery and early clinical development with Pfizer’s global research and development and commercialization capabilities, we have an opportunity not only to strengthen our pipeline, but to accelerate the delivery of breakthroughs that can redefine standards of care and make a meaningful difference in patients’ lives,” Jeff Legos, Pfizer’s chief oncology officer, said in a statement.

Racing the ‘patent cliff’

Like other biopharma giants, Pfizer is racing the proverbial “patent cliff” by building a pipeline of new treatments capable of recouping the billions that it stands to lose in coming years as its aging blockbuster drugs lose patent exclusivity in the U.S. and other key markets.

GEN’s A-List of Top 20 Drugs Heading for the Patent Cliff through 2029 includes two Pfizer treatments. One is Prevnar 13/Prevenar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]), which lost U.S. exclusivity starting March 31; and the prostate cancer drug Xtandi® (enzalutamide), co-marketed with Astellas Pharma and set to lose U.S. exclusivity in 2027.

Pfizer generated $6.494 billion last year, up 1% from 2024, and another $1.69 billion in the first quarter, up 2% from a year ago, in revenues from its Prevnar family, which includes Prevnar 20/Prevenar 20 (Pneumococcal 20-valent Conjugate Vaccine), as well as the Prevnar 13/Prevenar 13 vaccines.

Xtandi racked up $2.194 billion in 2025, up 8% from a year earlier, and $444 million in Q1, down 3% from the year-ago quarter, in revenues in the U.S. and more than 90 other countries, including the EU and Japan—primarily reflecting alliance revenues and royalty revenues.

Oncology focus

Oncology is among therapeutic areas where Pfizer has sought to bolster its pipeline and portfolio of marketed drugs in recent years. The pharma giant acquired ADC-focused drug developer Seagen for $43 billion in 2023, a deal that cleared expected antitrust hurdles and doubled Pfizer’s oncology pipeline to some 60 programs spanning multiple modalities, including ADCs, small molecules, bispecifics and other immunotherapies.

Last year, Pfizer launched an up-to-$1.5 billion global ex-China licensing agreement with another Chinese biotech, 3SBio. In that deal, Pfizer agreed to pay $1.25 billion upfront, make a $100 million equity investment in 3SBio equity, and pay up to $150 million in return for an option for exclusive development and commercialization rights in China to SSGJ-707, a bispecific antibody targeting PD-1 and VEGF.

Outside of oncology, Pfizer acquired obesity drug developer Metsera for up-to-$10 billion last October following a bidding war with Novo Nordisk that ended with some help from Washington.

And in February, Pfizer inked a commercialization deal of undisclosed value with Chinese drug developer Hangzhou Sciwind Biosciences giving Pfizer exclusive commercialization rights in China to the obesity therapy ecnoglutide, an new‑generation cAMP‑biased glucagon-like peptide 1 (GLP‑1) receptor agonist delivered via injection.

While Innovent has successfully developed an obesity treatment, mazdutide, the company specializes in cancer drug development, building a combined portfolio and development pipeline of 37 programs—23 of them in oncology including the PD-1 inhibitor Tyvyt® (sintilimab). The fully human IgG4 monoclonal antibody was first approved in China in 2018 and is now indicated to treat three forms of non-small cell lung cancer, classic Hodgkin’s lymphoma, and forms of endometrial, gastric/esophageal, kidney, and liver cancers.

‘Greater speed and impact’

“By leveraging both companies’ complementary resources, we can develop our early-stage oncology pipeline with greater speed and impact to help bring innovative therapies to patients more efficiently worldwide,” stated Hui Zhou, MD, PhD, Innovent’s chief R&D officer for its oncology pipeline. “Furthermore, co-developing and co-commercializing key projects in the U.S. and Europe expands Innovent’s global reach.”

Innovent plans to carry out development of the Pfizer-partnered programs through Phase I, applying its discovery engine and robust early clinical capabilities, after which Pfizer will oversee future global development. Pfizer will receive an exclusive global license for four programs, and assume their global development costs, as well as an exclusive license outside Greater China for four other programs, having agreed to shoulder an unspecified majority of the development costs.

Pfizer and Innovent also agreed to co-develop four programs globally, sharing their development costs. The companies plan to co-commercialize in the U.S., the European Union (E.U.), and the United Kingdom (U.K.), agreeing in return to share their profits—while Innovent will retain Greater China rights to these programs.

Pfizer has agreed to pay Innovent $650 million upfront and up to $9.85 billion in payments tied to achieving development, regulatory, and commercial milestones. Pfizer also agreed to pay Innovent up to double-digit royalties on sales of each licensed product if approved, with the companies agreeing to share their profits in the U.S., the EU, and the U.K.

The collaboration transaction is expected to close in the third quarter, subject to regulatory approvals.

In October, Innovent launched an up to $11.4 billion collaboration with Takeda Pharmaceutical aimed at speeding up the development of Innovent’s next-generation immuno-oncology therapies as well as ADCs.

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Teclistamab Outperforms Standard Therapy in Relapsed Multiple Myeloma

The treatment landscape for multiple myeloma has undergone a dramatic transformation over the past decade, driven by a growing arsenal of immunotherapies that harness the patient’s own immune system to fight cancer. Now, results from a large international Phase III trial suggest that one of the newest entrants to this class, the bispecific antibody teclistamab, may be poised to move even earlier in the treatment paradigm.

The findings, published in the New England Journal of Medicine and presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that teclistamab significantly improved progression-free survival and depth of response compared with standard therapies in patients with relapsed multiple myeloma.

The study represents one of the strongest demonstrations to date that chemotherapy-free immunotherapy can outperform conventional approaches even after only a limited number of prior treatments.

Moving bispecific antibodies earlier in treatment

Teclistamab belongs to a rapidly expanding class of therapies known as bispecific antibodies. Unlike traditional monoclonal antibodies, bispecifics are engineered to bind two targets simultaneously. Teclistamab recognizes both BCMA, a protein expressed on multiple myeloma cells, and CD3 on T cells, effectively bringing immune cells into direct contact with tumor cells and triggering targeted cancer cell killing.

The therapy has already shown substantial activity in heavily pretreated patients with advanced disease. However, investigators wanted to determine whether moving the drug earlier in the disease course could provide even greater benefit.

“Now we have chemotherapy-free immunotherapy options for patients whose myeloma has relapsed for the first time,” said C. Ola Landgren, MD, chief of the Sylvester Myeloma Institute and senior author of the study. “We are seeing very deep responses and long clinical benefit from these therapies. This is part of a much bigger transformation happening in myeloma care.”

Landmark global trial

The Phase III MajesTEC-9 trial enrolled 593 patients across 24 countries. Participants had relapsed multiple myeloma after one to three prior lines of therapy, representing a patient population increasingly encountered in routine clinical practice.

Approximately three-quarters of patients had already become refractory to commonly used treatments, including immunomodulatory drugs such as lenalidomide and anti-CD38 therapies such as daratumumab. These patients typically face diminishing treatment options and shorter durations of disease control.

Patients were randomized to receive either teclistamab or standard treatment regimens.

The results demonstrated a clear advantage for the bispecific antibody.

After 18 months of follow-up, nearly 70% of patients treated with teclistamab remained free from disease progression, compared with only about 27% of patients receiving standard therapies.

The magnitude of benefit exceeded what many clinicians have come to expect in relapsed myeloma, where treatment resistance often emerges rapidly.

Deep remissions become increasingly common

Beyond delaying disease progression, teclistamab produced remarkably deep responses.

Nearly two-thirds of treated patients achieved complete remission, meaning no evidence of disease could be detected using conventional testing methods.

Another highlight was the frequency of minimal residual disease (MRD) negativity, an increasingly important endpoint in multiple myeloma research. MRD testing uses highly sensitive techniques capable of detecting tiny numbers of remaining cancer cells that standard assessments might miss.

Many patients receiving teclistamab achieved MRD-negative status, suggesting that the therapy may be capable of driving deep eradication of disease.

“To see that this drug is so efficacious and so safe across patients from all these locations worldwide is a very strong signal,” Landgren said. “To see that in patients who have been exposed and refractory to commonly used myeloma treatments is very important.”

The broader shift away from chemotherapy

The results reflect a larger evolution occurring throughout multiple myeloma treatment.

For decades, chemotherapy served as the backbone of therapy. Today, however, treatment increasingly revolves around immune-based approaches including monoclonal antibodies, CAR T-cell therapies, and bispecific antibodies.

Researchers are not only developing new immunotherapies but also moving them earlier into treatment algorithms, where the immune system may be more intact and capable of mounting stronger anti-tumor responses.

The success of teclistamab in earlier-relapse patients supports this strategy and raises the possibility that bispecific antibodies could eventually become standard components of frontline treatment.

Managing infection risk remains critical

Despite the encouraging efficacy results, teclistamab is not without challenges.

Because the therapy activates T cells and alters immune function, infection remains one of the most important safety considerations. The risk is particularly pronounced during the first several months of treatment, when immune suppression can occur as part of the therapeutic response.

To mitigate this risk, patients typically receive antiviral and antibiotic prophylaxis, undergo routine monitoring of immunoglobulin levels, and may receive supplemental immunoglobulin infusions when necessary.

Investigators reported that these risks were manageable with appropriate monitoring and supportive care, consistent with previous studies of bispecific antibodies.

Looking toward curative strategies

The success of teclistamab is part of a broader effort to transform multiple myeloma from a chronic relapsing disease into one that can potentially be controlled for extended periods, or perhaps one day cured.

Researchers are already investigating whether teclistamab and related bispecific antibodies can be incorporated into even earlier treatment settings, including newly diagnosed disease.

“For me, the goal is to develop curative strategies,” Landgren said. “We are working toward treatments that can either eliminate the disease entirely or control it for very long periods while minimizing the burden on patients and preserving quality of life.”

As bispecific antibodies continue to demonstrate increasingly durable responses, the field is moving closer to that goal. The MajesTEC-9 results suggest that immune-based therapies are no longer merely alternatives to conventional treatment, they may be emerging as the new standard for many patients with relapsed multiple myeloma.

The post Teclistamab Outperforms Standard Therapy in Relapsed Multiple Myeloma appeared first on Inside Precision Medicine.

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AI Chatbots Do Not Consistently Deliver Accurate Health Responses

A study into the responses of AI chatbots to everyday medical questions found that nearly 76% of the responses were accurate, according to investigators at Penn State University. Their research, published as a preprint in arXiv, found that while the AI chatbots could deliver useful information, the error rates remain high enough that they shouldn’t replace physicians for either diagnosing or suggesting treatments.

“Our work focuses explicitly on healthcare scenarios that the average internet user might ask AI, which is a perspective that prior research into large language models (LLMs) and healthcare hasn’t covered,” said the study’s senior author Amulya Yadav, PhD, associate professor of informatics and intelligent systems at Penn State. “We wanted to understand that if people are using LLMs like ChatGPT as a symptom health checker, like historically we’ve used Google, how accurate is the LLM in answering those queries, and how harmful could those responses be?”

The study examined a shift in how people seek healthcare information online. According to the researchers, “over half of U.S. adults consult online resources for medical advice,” a trend that is particularly prominent in younger adults, with near one-quarter of people under 30 using AI for health-related guidance.

The research was designed to evaluate AI performance in real-world everyday health communication, rather than in controlled testing environments that rely on medical licensing exams or clinical case studies. The researchers wrote that earlier studies “fail to account for the unstructured and often ambiguous nature of general-purpose everyday health inquiries.”

To conduct the study, the Penn State team organized a weeklong “Diagnose-a-thon” competition involving 34 participants, including faculty, staff, undergraduate students and graduate students. Participants submitted 212 prompts describing real or imagined health concerns from both patient and physician perspectives. They were allowed to use one of four publicly accessible AI models: ChatGPT-4o, ChatGPT-3.5, Gemini-1.5 Pro or Llama3-8b.

“One of the strengths of our study is we’re essentially trying to replicate real-world usage of LLMs by telling participants to choose the LLM of their choice and use it as they would on a normal day,” said lead author Bonam Mingole, a doctoral candidate in information sciences and technology at Penn State. “This type of participatory research is so important for understanding how the public uses AI in their daily life.”

Nine board-certified physicians evaluated the AI-generated responses to the prompts using a six-point scale to measure validity, quality of information, understanding and reasoning, and potential harm. About 76% of responses were considered accurate overall and showed that ChatGPT-4o was the most accurate at 84.62%, while Llama3-8b had the lowest at 50%.

The results also showed significant differences across medical specialties. Obstetrics and gynecology and otolaryngology generated the strongest AI performance, with high validity scores and low harm scores. Internal medicine, neurology, and dermatology produced the weakest results, including lower validity and higher risk of harmful responses.

The responses also shined a light on a continuing problem in healthcare research that leads to disparities in care. “The lower quality LLM-generated responses for underrepresented patient populations and rare medical conditions raises concerns about the potential of LLMs to inadvertently exacerbate existing healthcare disparities,” the researchers wrote. They added that addressing these issues “requires more than technical mechanisms, it calls for a broader commitment to equity in the data collection, model development, and evaluation processes.”

How the prompts were written also influenced AI performance. Queries between 60 and 250 characters produced the most accurate responses, while very specific prompts also improved output quality. Interestingly, the physician reviewers perceived greater risk of harm in responses generated from prompts that attempted to be written from a medical professional’s perspective.

To test whether specialized medical training could improve the answer generated by AI, the investigators enhanced the LLMs using Retrieval-Augmented Generation, by training them with medical textbooks, clinical guidelines and peer-reviewed research that is typically included in medical school curriculums.

Performance of the LLMs trained in this way were mixed. The physician reviewers preferred the baseline versions of Gemini and Llama over their medically trained counterparts, while no meaningful preference emerged for the ChatGPT models.

The researchers will now look to expand their study by collecting larger and more balanced datasets of crowdsourced health prompts and looking for ways to discourage overreliance on AI-generated medical advice.

“Like it or not, people will continue to use AI for diagnosing their health problems,” said study co-author S. Shyam Sundar, PhD, a professor in the Center for Socially Responsible AI at Penn State. “By understanding their use patterns and testing the validity of AI performance, our project helps advance literacy on the best and worst uses of AI for medical advice.”

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AI-Powered Pan-Cancer Map Reveals Tertiary Lymphoid Structures

Researchers at The University of Texas MD Anderson Cancer Center have developed a spatial atlas of specialized immune structures known as tertiary lymphoid structures (TLSs), across multiple cancer types, revealing how key features vary across tumor types and influence patient outcomes. Led by Linghua Wang, MD, PhD, professor of genomic medicine, executive director and head of the Center for Cellular Language Intelligence, associate member of the James P. Allison Institute™, and focus area co-lead with the Institute for Data Science in Oncology at UT MD Anderson, the team developed scalable artificial intelligence (AI) frameworks to detect, profile and classify TLSs from spatial omics data and routine pathology slides.

Tumors can contain TLSs with very different levels of organization, cellular composition and spatial relationships within tumor cells and the researchers’ newly reported study showed that these differences carry important biological and clinical information. The team suggests that their first-of-its-kind atlas indicates that TLS maturation state, spatial location, and composition within tumors may provide clinically meaningful information about cancer prognosis and treatment response. They also created a composite scoring system to more effectively stratify patients by prognosis and treatment response across different cancer types and treatment contexts.

“Prior to this study, most of the focus on TLSs as biomarkers was simply on whether or not they were present and, in some cases, whether they were mature,” Wang said. “Here, we show that we can go much deeper. TLSs in tumor tissues are much more complex than that. Their maturation state, spatial location and composition within tumors can tell us critical information about the tumor immune microenvironment, treatment response and clinical outcomes.”

Wang is senior author of the team’s published paper in Science, Titled “Pan-cancer spatial atlas of tertiary lymphoid structures.” In their paper the team concluded, “Together, this work provides a comprehensive landscape of TLS heterogeneity across cancers and establishes spatially defined TLS features and artificial intelligence (AI)–driven TLS classification as scalable tools for precision immuno-oncology.”

The immune system’s response to a tumor is a highly coordinated effort taking place within the tumor microenvironment (TME), the authors explained. In some tumors, immune cells come together to form organized structures called tertiary lymphoid structures, or TLSs. These structures operate as local immune “hubs,” bringing together B cells, T cells, antigen-presenting cells and other supporting cells that help coordinate antitumor immune responses. “TLSs frequently develop within the tumor microenvironment (TME) and have been observed across a broad range of human solid tumors, where they contribute to lymphocyte activation, B cell immunity, and regulation of antitumor immune responses,” they noted.

Previous studies have shown that TLSs—particularly those that are more mature—are often associated with better patient outcomes and improved responses to immunotherapy across a variety of cancer types. “The presence of TLSs has been linked to favorable responses to immune checkpoint blockade (ICB) and prolonged survival across multiple cancer types, fueling interest in TLSs as predictive biomarkers, prognostic indicators, and potential therapeutic targets. However, the presence of TLSs alone does not tell the whole story,” the scientists noted. “While it is well acknowledged that TLSs are important in cancer, our understanding of their cellular and molecular heterogeneity has remained limited, especially in their natural spatial context across large cohorts of human tumor samples.”

“Although TLS presence has been associated with enhanced immune activity and improved outcomes in several settings, their maturation states, spatial locations relative to tumors, and context-dependent associations have not been systematically characterized at a pan-cancer scale, limiting a unified view of TLS biology and clinical utility,” they stated.

For their reported study the team developed scalable computational frameworks to precisely detect, comprehensively profile and classify TLSs from spatial omics data. Leveraging this framework, the team built a pan-cancer spatial atlas of TLSs across 340 samples from 12 cancer types. This atlas allowed them to examine the TLS landscape in tumor tissues, to define how TLSs vary in key features, and identify transcriptional programs associated with TLS maturation. “By integrating transcriptomic, spatial, histopathological, and clinical data, we systematically characterized TLS abundance, spatial distribution, size, maturation states, and transcriptomic programs in 340 ST samples across 12 cancer types and examined their interactions with tumor cells and the surrounding TME,” they wrote in summary.

The study found that TLSs vary substantially across tissues. As TLSs mature, they become more organized and undergo coordinated changes in immune, stromal, and vascular components. Further, their proximity to tumor cells is associated with spatial gradients of tumor signaling. These findings suggest that TLS maturation and spatial context are linked to distinct tumor signaling environments and may reflect important features of the tumor immune microenvironment.

To make these insights more scalable, the team developed an AI framework to rapidly identify and classify TLSs from hematoxylin and eosin (H&E) whole-slide images (WSIs), pathology images that are routinely used in daily clinical care. Training this AI model makes the process of analyzing TLSs more easily translatable to the clinic, while also making the process significantly faster and more scalable. The AI framework enabled the researchers to go one step further, evaluating 25,088 TLSs from more than 3,000 whole-slide images across 10 independent cohorts and developing a TLS “composition score” for a given patient’s tumor. “By developing a scalable AI-enabled framework to detect and classify TLSs directly from routine H&E WSIs, we have extended TLS analysis from limited spatial datasets to thousands of tumors,” the team noted.

This composition score captures not only the number of TLSs, but also their maturation states within a tumor. This method significantly outperformed conventional TLS measures in stratifying patients by prognosis and treatment response, suggesting that a more detailed view of TLS biology, accounting for maturation state, may provide more clinically meaningful information than TLS presence alone. “… we developed a data-driven, unsupervised TLS-based patient stratification framework that outperformed existing approaches in prognostic evaluation,” they commented.

The TLS composite scoring approach must be validated in prospective clinical trials. If successful, the framework could support broader integration of TLS profiling into routine pathology workflows, since it uses routine pathology images. “Together, this work establishes generalizable and clinically scalable frameworks for TLS profiling and highlights TLS state composition as a key dimension of tumor immune organization with translational relevance. It also provides a foundation for prospective evaluation of TLS-informed biomarkers in clinical settings,” they stated.

The findings raise important biological and therapeutic questions, the researchers suggest. One important observation from the study is that many TLSs in tumor tissues remain immature, and some are located away from tumor regions rather than within or adjacent to tumor cells. This suggests that future studies should investigate how to promote TLSs toward more mature and functional states, and how to enhance their spatial interaction with tumor cells and the broader tumor microenvironment.

These efforts may help identify therapeutic strategies to promote effective TLS formation and maturation and enhance TLS-associated anti-tumor immune responses. In their paper the team concluded, “Prospective studies should test whether TLS composition improves risk and response modelling beyond established clinicopathologic and molecular predictors, and whether TLS-informed stratification can guide clinical trial design or therapeutic modulation strategies.”

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Illumina Announces MRD Kit Ahead of ASCO Meeting

Ahead of the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, kicking off this weekend, Illumina has announced a new molecular residual disease (MRD) product. The distributed kit enables solid tumor MRD and blood cancer genomic profiling and, the company says, will enable more labs to adopt MRD detection for clinical research.

It is the first in a new portfolio of WGS oncology research offerings, with additional solutions in development leveraging the latest advancements of the NovaSeq X. Illumina’s MRD research solution is available today for early access to select partners and will launch for global customers next year.

“In precision healthcare, early and accurate detection of molecular residual disease is critical to monitoring patients during and after cancer treatment,” said Todd Christian, senior vice president of Services, Arrays, and Genomic Access at Illumina. “Illumina’s MRD solution for clinical research leverages the advanced sensitivity of whole-genome sequencing, coupled with unparalleled analysis, to enable our customers to more easily deliver the most precise information to advance MRD research. We aim to make WGS in oncology more accessible and scalable to support the integration of precision solutions into the standard of care.”

The MRD solution supports fingerprinting through solid tumor samples, and MRD detection using blood samples, all compatible on NovaSeq Systems. The end-to-end research workflow can be completed in as fast as five days and is optimized for analytical sensitivity as low as 10 ppm, particularly important for early-stage and low-shedding tumors, including breast, ovarian, and renal.

Illumina’s DRAGEN MRD analysis connects each fingerprint to serial circulating tumor DNA (ctDNA). The new MRD solution has been optimized across thousands of samples to develop and demonstrate a ctDNA detection algorithm with 99.5% analytical specificity to distinguish true tumor signals from background noise.

Mayo Clinic evaluated the solution on a small sample cohort and found high concordance among previously characterized paired samples. The results were also highly correlated with clinical and imaging results over time. The team is planning to expand the cohort for additional research with Mayo Clinic and other academic partners.

“We are looking forward to participating in early access and evidence generation for a tumor-informed, non-bespoke whole-genome sequencing approach to MRD,” said Gang Zheng, MD, PhD and professor of Laboratory Medicine and Pathology at Mayo Clinic. “We have seen early pilot results across several solid tumor clinical samples that demonstrated the potential utility of highly sensitive solid tumor MRD detection, and we continue to pilot technologies that help us efficiently progress in our ability to analyze and translate complex genomic arrays.”

Built on recently announced NovaSeq X advancements, including 35B output and Q70 quality scores, a complementary research workflow that will deliver ultra-sensitive MRD detection in the single-digit ppm range leveraging duplex reads is currently in development.

Illumina’s new oncology portfolio builds upon the integrated ecosystem of workflows, data and community across genomic, multiomic, and clinical research applications—anchored on the NovaSeq X.

Illumina and Bristol Myers Squibb will jointly present a poster at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, May 31, from 9:00 a.m. to 12:00 p.m. (abstract ID 8591, poster board #381, Lung Cancer: Non–Small Cell Metastatic track).

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Kenya court suspends U.S. plan for Ebola quarantine facility for Americans

NAIROBI, Kenya — A court in Kenya on Friday suspended a U.S. plan to establish a quarantine facility for Americans exposed to a rare type of Ebola virus spreading in northeastern Congo, following a backlash by medical workers and activists.

A U.S. administration official said on Wednesday that the U.S. was planning to send Americans who are exposed to Ebola while abroad to a new facility in Kenya instead of flying them home. The official spoke on condition of anonymity to share the administration’s plans. It was unclear where in Kenya the new facility will be built or whether the Kenyan government has signed off on the plan.

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STAT+: Pharmalittle: We’re reading about Replimune drug getting third try at FDA approval, a Pfizer deal in China, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda, so far, is very low-key. We hope to catch up on our reading, promenade with the official mascots, and take a few naps. We may also manicure the Pharmalot grounds. And of course, we hope to hold still another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The choices are endless this time of year. In particular, the great outdoors are beckoning — trails can be hiked, streets can be walked, country roads can be driven. If this fails, there is always the great indoors. You could cook a fabulous meal, shop for something that looks spiffy, or binge watch on the telly. Or you could be totally zen and do absolutely nothing. Well, whatever you prefer, have a grand time. But be safe. Enjoy, and see you soon…

A U.S. Food and Drug Administration advisory panel recommended updating this fall’s Covid shots to target the XFG variant, a fast-growing strain nicknamed “stratus,” NBC News tells us. The recommendation — from the FDA’s Vaccines and Related Biological Products Advisory Committee — is meant to help vaccine makers prepare shots for the fall and winter, when Covid infections typically rise. The meeting was the agency’s first since FDA Commissioner Marty Makary resigned. His resignation did not play a role; the meeting was already on the calendar before he resigned. Makary drew criticism last year after the agency imposed stricter requirements on who could get Covid shots.

Pfizer and China’s Innovent Biologics agreed to a global licensing and collaboration deal worth up to $10.5 billion to develop 12 early-stage cancer medicines, as global drugmakers race ​to tap China’s booming biotech pipeline, Reuters says. The deal also includes a $650 million upfront payment ​to Innovent and up to $9.85 billion in potential development, regulatory and ⁠commercial milestone payments. The value of such deals in the greater China region rose nearly tenfold from 2021 to an unprecedented $137.7 billion last year. The partnership spans a portfolio of antibody-drug conjugates ​with novel differentiated payloads and multi-specific antibodies, comprising eight Innovent-originated early-stage assets and four Pfizer-proposed discovery ‌programs.

The World Health Organization identified drugs from Regeneron Pharmaceutical, Mapp Bio, and Gilead Sciences that should be fast-tracked through clinical testing to respond to the current Ebola outbreak, Pharmaphorum notes. The WHO’s independent experts have said Regeneron’s maftivimab, Mapp’s MBP134, and Gilead’s remdesivir should be studied in patients infected with the Bundibugyo form of Ebola currently infecting more than 1,000 people in the Democratic Republic of the Congo, with cases also reported in neighbouring Uganda. At last count, the Bundibugyo outbreak had led to 10 confirmed deaths, with another 223 suspected, although the WHO has said it could be much larger as the virus is thought to have circulated undetected for some time.

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