pembrolizumab
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The personalized mRNA cancer vaccine intismeran, developed by Moderna and Merck, reduced the risk of melanoma recurrence or death by 42% when combined with pembrolizumab in a phase III trial of 1,137 patients with a median follow-up of about 25 months. The data will be presented at the ESMO meeting. The vaccine is tailored to neoantigens from each patient's tumor and did not add major serious side effects. Experts consider the magnitude of risk reduction clinically meaningful, but long-term efficacy and which patients benefit still require further analysis.
Excerpted from nature.com
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- x.comneoHIP at #ESMO26
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- nature.comPickModerna mRNA vaccine almost halves the risk of skin cancer returning
The personalized mRNA cancer vaccine intismeran, developed by Moderna and Merck, reduced the risk of melanoma recurrence or death by 42% when combined with pembrolizumab in a phase III trial of 1,137 patients with a median follow-up of about 25 months. The data will be presented at the ESMO meeting. The vaccine is tailored to neoantigens from each patient's tumor and did not add major serious side effects. Experts consider the magnitude of risk reduction clinically meaningful, but long-term efficacy and which patients benefit still require further analysis.
- mp.weixin.qq.comPickDetailed Phase 3 Data for intismeran autogene Plus Keytruda in Melanoma Show 42% Lower Recurrence or Death Risk
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%.
- fda.govPickFDA grants traditional approval for pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for unresectable or metastatic TMB-H solid tumors with updated indication
The FDA has converted pembrolizumab's indication for unresectable or metastatic TMB-H solid tumors to traditional approval, with TMB-H now defined as at least 13 mut/Mb.
- biocentury.comPickModerna’s melanoma vaccine data bring adoption test into focus
Moderna's personalized cancer vaccine intismeran autogene combined with Keytruda reduced the risk of recurrence or death by 42% (HR=0.58, p<0.001) in a Phase III melanoma trial, validating the benefit of personalized vaccines in adjuvant therapy. But the therapy faces challenges from complex personalized manufacturing, high costs and competition from neoadjuvant immunotherapy strategies, and the trial did not directly compare against neoadjuvant regimens, so commercial adoption remains to be weighed.
- biocentury.comPickMerck and Moderna’s melanoma vaccine data bring adoption test into focus
Merck and Moderna's intismeran autogene combined with Keytruda pembrolizumab reduced the risk of recurrence or death by 42% in a Phase III melanoma trial (HR=0.58; p<0.001). The article focuses on adoption, weighing the added benefit against the anticipated cost and manufacturing complexity of individualized treatment. The trial did not compare competing paths such as starting immunotherapy before surgery, a gap affecting its positioning in melanoma care.
- youtube.comA BRCA1 Carrier's Genetic Screening, Preventive Surgery and Pregnancy Breast Cancer Journey
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.
- fda.govVerified Clinical Benefit | Cancer Accelerated Approvals
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.
- fda.govOther | Cancer Accelerated Approvals
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.
- mp.weixin.qq.comBNT113 Plus Pembrolizumab Misses PFS Endpoint in HPV16-Positive Head and Neck Cancer Trial
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.
- mp.weixin.qq.comPickBioNTech BNT113 Plus Pembrolizumab Misses PFS Endpoint in AHEAD-MERIT HPV16-Positive HNSCC Trial
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.
- mp.weixin.qq.comPickIvonescimab Beats Pembrolizumab on Overall Survival in Frontline PD-L1-Positive Advanced Lung Cancer
Ivonescimab, Akesu's bispecific antibody, beat pembrolizumab head-to-head as first-line monotherapy in PD-L1-positive advanced lung cancer, with median overall survival of 30.8 months versus 22.6 months. The risk of death fell 27 percent, with P value 0.009, a statistically significant result presented at the World Conference on Lung Cancer. Pembrolizumab, long the world's top-selling drug at 31.68 billion dollars a year, now faces a direct survival challenge.
- mp.weixin.qq.comBioNTech BNT113 Plus Pembrolizumab Misses PFS Endpoint in Head and Neck Cancer Trial
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.
- mp.weixin.qq.comFDA Accepts First US Filing for Pembrolizumab Biosimilar FYB20 from Formycon and Zydus
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.
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Heat now 127·Peak in the comparable set 169 (Oct 25 00:00)·Change over 24h in the comparable set +1%·Participants now 37
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