April 17–22, 2026 · San Diego · 2418 items
← MRD / ctDNA / DTP: from detection to treatment decisions
51 people · 51 posts · 4 abstracts
Heat now 4·Peak in the comparable set 4 (Oct 23 03:00)·Change over 24h in the comparable set –·Participants now 5
Participants counted above, heat below. The trend compares only the participants observed in full throughout, so its set can be smaller than the heat figure itself. Move the pointer or click the chart for an hour's reading; the left and right arrow keys work too.
Nivolumab, pembrolizumab and durvalumab sit in this direction not as new drugs, but because perioperative IO trials wrote ctDNA into the stratification.
Timothy A. Yap, Andrae Vandross, Jenny Amaya-Amaya, Chris N. Barnes, Shuguang Ma, Martin Decaris, Keithryn Nicolas, Alexander Spira, Jacqueline Brown, Patricia LoRusso, Manish R. Sharma
Read the abstract →Karen L. Reckamp, Mary W. Redman, Konstantin H. Dragnev, Maya Khalil, Brian S. Henick, James Moon, Pasarlai Ahmadzai, Michael LeBlanc, Daniel R. Carrizosa, Paul J. Hesketh, Ellen V. Sigal, Jeff Allen, Andreas N. Saltos, Bryan A. Faller, Roy S. Herbst, Charles D. Blanke, Jhanelle E. Gray
Read the abstract →Salah-Eddine Bentebibel, Daniel J McGrail, Veena Kochat, Emre Arslan, Reham Abdel-Wahab, Sung-Nam Cho, Xiaodong Yang, Daniel H Johnson, Rodabe N Amaria, Isabella C Glitza, Patrick Hwu, Hussein A Tawbi, Jared K Burks, Michael A Davies, Kunal Rai, Suhendan Ekmekcioglu, Adi Diab
Read the abstract →Barbara Burtness, Ravindra Uppaluri, Michael J. Dennis, Annette M. Lim, Richard A. Scolyer, Erin Alesi, Ayako Wakatsuki Pedersen, Amy Wesa, Ravi K. Adapala, Ulla Kring Hansen, Marcos Iglesias, Bushi Wang, Cecilie Abildgaard, Qasim Ahmad, Francois Ringeisen, Georgina V. Long, Robert I. Haddad
Read the abstract →Moderna's personalized cancer vaccine intismeran autogene combined with Keytruda reduced the risk of recurrence or death by 42% in a Phase III melanoma trial (HR=0.58, p<0.001), validating the benefit of personalized vaccines in adjuvant therapy. But the therapy faces challenges from personalized manufacturing complexity, high costs, and competition from neoadjuvant immunotherapy strategies; the trial did not directly compare against neoadjuvant regimens, and commercial adoption remains to be weighed.
Why it matters: The article notes the vaccine beat adjuvant Keytruda but commercialization faces high costs, manufacturing complexity, and neoadjuvant immunotherapy competition.
Merck and Moderna have announced detailed Phase 3 results for the personalized mRNA cancer therapy intismeran autogene combined with Keytruda (pembrolizumab) in melanoma. Compared with Keytruda alone, the combination reduced the risk of disease recurrence or death by 42%.
Why it matters: The brief gives the specific 42% reduction in recurrence or death risk versus Keytruda alone, comparable to existing readouts in melanoma adjuvant therapy.
The FDA has converted the indication for pembrolizumab, as monotherapy or with berahyaluronidase alfa-pmph, in unresectable or metastatic TMB-H solid tumors to traditional approval, with TMB-H now defined as at least 13 mut/Mb.
Why it matters: The TMB-H threshold rises from ≥10 to ≥13 mut/Mb because efficacy was not confirmed in patients with 10 to <13 mut/Mb.
BRCA1 carrier Carolyn Searles underwent a preventive bilateral mastectomy in November 2021, yet was diagnosed with breast cancer at 16 weeks of pregnancy in 2025. She received chemotherapy during pregnancy, delivered at 33 weeks and 4 days, added pembrolizumab after giving birth, and an MRI after her final chemotherapy showed no signs of cancer; she is now in remission. She urges anyone with a family history to get genetic testing.
The DFS benefit of adding belzutifan to adjuvant pembrolizumab in LITESPARK-022 attenuates after treatment ends, a reconstructed individual patient data analysis of ten phase 3 adjuvant renal cell carcinoma trials finds. The hazard ratio was 0.55 (0.43-0.71) before month 12 but 1.16 (0.87-1.54) afterwards, a post/pre ratio of 2.10, matching trials whose benefit faded (SORCE, PROTECT) rather than KEYNOTE-564, where it persisted. The 24-month restricted mean survival time difference was 1.34 months (0.73-1.95), and durability of the absolute advantage is uncertain, so single-HR projections should be avoided.
FDA granted traditional approval on 10/16/2026 to Keytruda Qvantig... correction: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for adults and patients 12 years and older with unresectable or metastatic TMB-H (≥10 mut/Mb) solid tumors, as determined by an FDA-approved test, that progressed after prior treatment with no satisfactory alternative options. The accelerated approval for this formulation was filed 9/19/2025. Separately, Lunsumio Velo (mosunetuzumab-axgb) for relapsed or refractory follicular lymphoma after two or more systemic lines, filed 12/19/2025, remains ongoing, as do three Brukinsa (zanubrutinib) accelerated approvals dated 6/10/2025 covering MCL, MZL and FL with obinutuzumab.
The FDA lists oncology accelerated approvals that have since had clinical benefit verified, spanning drugs from Keytruda and Opdivo to Tecvayli and Imdelltra. Each entry pairs the original accelerated approval date with its verification date, for example Keytruda in TMB-high solid tumors and Breyanzi in relapsed or refractory follicular lymphoma. The list covers indications across solid tumors and blood cancers, including Retevmo in RET fusion solid tumors, Tecvayli in multiple myeloma and Jaypirca in CLL/SLL.
BioNTech's mRNA cancer immunotherapy candidate BNT113, combined with pembrolizumab, failed to significantly improve progression-free survival compared with pembrolizumab alone in patients with metastatic HPV16-positive head and neck cancer, missing the first dual primary endpoint of the phase II/III AHEAD-MERIT trial. The trial continues to assess overall survival, the second dual primary endpoint.
The FDA has accepted for review the marketing application for FYB20, a biosimilar of pembrolizumab developed by Formycon, which filed the submission jointly with Zydus. It is the first pembrolizumab biosimilar submitted for approval in the US. Formycon licensed FYB20 rights for the US and Canada to Zydus and for the Middle East and North Africa to MS Pharma in December 2025, and Asia-Pacific rights to Lotus Pharmaceutical in February 2026.
BNT113 plus pembrolizumab failed to significantly improve progression-free survival versus pembrolizumab alone in first-line HPV16-positive head and neck squamous cell carcinoma, according to first topline results from the phase 2/3 AHEAD-MERIT trial (NCT04534205). PFS was a dual primary endpoint. BNT113 is an mRNA tumor immunotherapy encoding the HPV16 E6 and E7 proteins.
Why it matters: First phase 3 failure for a BioNTech mRNA cancer vaccine candidate in a key indication.
The AHEAD-MERIT phase 2/3 trial found that the mRNA cancer immunotherapy candidate BNT113 plus pembrolizumab did not improve progression-free survival versus pembrolizumab alone in metastatic HPV16-positive head and neck cancer, missing the first dual primary endpoint. The trial continues to assess the second dual primary endpoint, overall survival.
An encapsulated cell-based "biologics factory" using an immunomodulatory alginate formulation sustained stable serum titers of the HIV-neutralizing mAb 3BNC117 for 1 year in immunocompetent mice, supported by an anti-inflammatory, proresolving immune niche that attenuates fibrosis. The platform produced 13 diverse mAbs from an allogeneic cell chassis, and in a nonhuman primate subcutaneous implant maintained stable ipilimumab titers for more than 6 months with no detectable toxicity, antidrug antibodies, or adverse events across a three-dose escalation. A retrievable macrodevice allows on-demand termination and dose-proportional tuning, pointing toward replacing frequent injections with single-administration therapy.
Why it matters: It shows a single implant can deliver monoclonal antibodies for months to a year, replacing repeated injections.
The New England Journal of Medicine on October 1, 2026 (Volume 395, Issue 13, pages 1347-1348) published a short piece on adjuvant pembrolizumab plus belzutifan for renal-cell carcinoma. The original contains bibliographic information only; the text provides no trial name, sample size, endpoints, or response rates that can be verified.
China's NMPA has approved Merck's subcutaneous formulation of the PD-1 inhibitor pembrolizumab, covering 19 solid tumour indications, making it the first and currently only subcutaneous PD-1 inhibitor approved in China. The approval, announced on 29 September 2026, is based on data from study MK-3475A-D77. The approval covers the same indication set as the existing intravenous formulation.
Why it matters: First subcutaneous PD-1 inhibitor approval in China affects a top-selling oncology drug's delivery options.
China's NMPA approved MSD's subcutaneous pembrolizumab injection (MK-3475A) on September 28, per the agency's website. The formulation, known as a subcutaneous version of Keytruda, had already been approved by the US FDA in September 2025 as Keytruda QLEX and in the EU in November 2025. The approval gives pembrolizumab a new route of administration in China.
Tissue-resident CD4+ memory T cells mark which high-grade gliomas respond to combined PD-1 and CTLA-4 inhibition. In a syngeneic hypermutated glioma model, response involved clonal expansion of tumor-reactive cytotoxic T cells and infiltration of CXCR6+ CD4+ Trm cells, with CD4 stem-like memory cells showing interferon responses rather than exhaustion. In IDH1 wildtype glioblastoma patients treated with neoadjuvant pembrolizumab, CD4+ Trm association with prolonged overall survival was confirmed.
Why it matters: Identifies a T-cell subset that predicts checkpoint inhibitor response and survival in glioblastoma.