pembrolizumab
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Pembrolizumab's dominance as the backbone of cancer immunotherapy is being tested on several fronts. Moderna and Merck reported that their personalized neoantigen vaccine intismeran autogene plus Keytruda improved recurrence-free survival and distant metastasis-free survival in an interim analysis of the Phase III INTerpath-001 trial in resected melanoma, the first key Phase III evidence for such vaccines in the adjuvant setting. AstraZeneca, meanwhile, stopped its Phase 3 eVOLVE-Lung02 trial after volrustomig plus chemotherapy was not expected to beat pembrolizumab on PFS or OS in first-line lung cancer. AbbVie has registered a 940-patient Phase III trial of ABBV-1480, a PD-1/VEGF bispecific licensed from RemeGen for $650 million upfront, against pembrolizumab plus chemotherapy in first-line non-small cell lung cancer, starting September 2026. Whether the bispecific or vaccine approaches can unseat pembrolizumab is the central open question.
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- 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 the indication for pembrolizumab in unresectable or metastatic TMB-H solid tumors to traditional approval, with TMB-H now defined as ≥13 mut/Mb.
- 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.
- medrxiv.orgDoes the Disease-free Survival Benefit of Adding Belzutifan to Adjuvant Pembrolizumab Persist Beyond the Planned Treatment Period? A Reconstructed Individual Patient Data Analysis of Phase 3 Renal Cell Carcinoma Trials
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.
- 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.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.
- clinicaltrials.govLabyrinthin Vaccination in Veterans With Lung Adenocarcinoma
- Sci AdvPickOnce yearly cell-based therapy for sustained and dose-tunable delivery of monoclonal antibodies.
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.
- nejm.orgAdjuvant Pembrolizumab plus Belzutifan for Renal-Cell Carcinoma
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.
- mp.weixin.qq.comPickNMPA Approves Subcutaneous Pembrolizumab, First of Its Kind in China
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.
- mp.weixin.qq.comNMPA Approves MSD's Subcutaneous Pembrolizumab MK-3475A in China
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.
- biorxiv.orgPickTissue resident CD4+ memory T-cells mark response to immune checkpoint inhibition in high-grade glioma
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.
- mp.weixin.qq.comNMPA Approves Merck's Subcutaneous Pembrolizumab, First PD-1 Injection of Its Kind in China
China's NMPA has approved Merck's pembrolizumab injection for subcutaneous use (MK-3475A), making it the first subcutaneous PD-1 monoclonal antibody approved in the country. The formulation combines pembrolizumab with berahyaluronidase alfa (ALT-B4), a recombinant human hyaluronidase variant developed and manufactured by South Korea's Alteogen. The approval appeared on the NMPA website on September 28.
- medrxiv.orgPickTumour extrinsic neutrophil regulation in mesothelioma correlates with responsiveness to AXL and PD1 inhibition in MIST3, a phase IIA clinical trial
AXL and PD1 inhibition with bemcentinib plus pembrolizumab met its primary endpoint in the phase IIA MIST3 trial in ICB naïve-relapsed mesothelioma, with a 12-week disease control rate of 46.2% (90% CI 29.2-63.8%); grade 3 or greater adverse events occurred in 53.9% of patients. Multiomic analyses linked response to NF2 loss, immune response signalling, epithelial mesenchymal transition, and neutrophil-related transcriptional programmes including SPI1, ETS2 and FLI1 activation. Gut microbiota composition differed between responders and non-responders and correlated with neutrophil-associated transcription programmes, IRF3 and TLR2.
- mp.weixin.qq.comPickAK112 Extends Overall Survival Over Pembrolizumab in HARMONi-2 Phase 3 NSCLC Trial
Ivonescimab (AK112) significantly improved overall survival versus pembrolizumab monotherapy in the phase 3 HARMONi-2 trial, raising median OS to 30.75 months from 22.57 months and reducing the risk of death by 27% in first-line advanced wild-type NSCLC with TPS at least 1%. The OS result, presented at WCLC, follows the previously reported PFS benefit, with median PFS of 11.1 months versus 5.8 months (HR=0.51). AK112 is the first domestic Chinese innovative drug to beat pembrolizumab head-to-head in a phase 3 lung cancer trial.
- mp.weixin.qq.comPickModerna mRNA-4157 Personalized Neoantigen Vaccine with Pembrolizumab Improves RFS and DMFS in Phase III Melanoma
In a randomized, double-blind, active-controlled phase III trial in high-risk melanoma, Moderna's personalized neoantigen vaccine mRNA-4157 combined with pembrolizumab significantly improved both recurrence-free survival and distant metastasis-free survival over pembrolizumab alone. The article calls it the first personalized neoantigen cancer vaccine to succeed in a large randomized phase III trial. Tumor sequencing selects up to 34 patient-specific neoantigens; the mRNA vaccine is delivered by LNP into dendritic cells, activating endogenous T cells and inducing epitope spreading.
- mp.weixin.qq.comPickModerna and Merck Announce intismeran Plus KEYTRUDA Adjuvant Melanoma Trial Hits RFS and DMFS Endpoints
Merck and Moderna jointly announced that the Phase III INTerpath-001 trial of intismeran autogene (V940/mRNA-4157) combined with KEYTRUDA (pembrolizumab) as adjuvant therapy for completely resected stage IIB-IV melanoma met both its primary endpoint of recurrence-free survival (RFS) and key secondary endpoint of distant metastasis-free survival (DMFS). The companies plan to present detailed data at an upcoming international medical conference.
- mp.weixin.qq.comPickModerna and Merck intismeran plus pembrolizumab posts positive Phase III topline in melanoma adjuvant therapy
Moderna and Merck jointly announced that the Phase III INTerpath-001 trial of the personalized mRNA neoantigen therapy intismeran (V940/mRNA-4157) combined with pembrolizumab as adjuvant therapy for melanoma met positive topline results. Each intismeran course encodes up to 34 neoantigens, tailored to each patient's tumor mutation profile; Moderna shares surged 177% on the news.
- mp.weixin.qq.comPickMerck and Moderna mRNA Cancer Vaccine Phase III Trial Meets Primary Endpoint, Reducing Melanoma Recurrence and Metastasis Risk
Merck and Moderna's individualized mRNA neoantigen therapy intismeran autogene, combined with KEYTRUDA as adjuvant therapy for patients with fully resected stage IIB-IV melanoma, met the primary endpoint of recurrence-free survival (RFS) and the key secondary endpoint of distant metastasis-free survival (DMFS) in a Phase III trial.
- biocentury.comPickModerna, Merck Phase III win opens door to personalized neoantigen vaccines
An interim analysis of the Phase III INTerpath-001 trial, run by Moderna and Merck, met its primary endpoint. Adjuvant treatment with intismeran autogene plus Keytruda improved recurrence-free survival (RFS) in patients with completely resected stage IIB-IV melanoma and met the key secondary endpoint of distant metastasis-free survival (DMFS). The results provide key Phase III evidence for personalized neoantigen vaccines in melanoma adjuvant therapy.
- mp.weixin.qq.comPickAstraZeneca Stops Phase 3 eVOLVE-Lung02 as volrustomig Fails to Beat Pembrolizumab in First-Line Lung Cancer
On August 17, 2026, AstraZeneca announced termination of the phase 3 eVOLVE-Lung02 study. The trial evaluated the PD-1/CTLA-4 bispecific antibody volrustomig (MEDI572) plus chemotherapy versus pembrolizumab as first-line lung cancer treatment, and was stopped early because the PFS and OS primary endpoints were not expected to be met.
- mp.weixin.qq.comPickAstraZeneca Discontinues Phase III NSCLC Trial of PD-1/CTLA-4 Bispecific Volrustomig
AstraZeneca has discontinued the Phase III eVOLVE-Lung02 trial of the PD-1/CTLA-4 bispecific antibody volrustomig, following a recommendation from an independent data monitoring committee after a planned review of trial data. The randomized, open-label, multicenter global Phase III trial enrolled 895 patients with metastatic NSCLC and PD-L1 expression below 50% across 25 countries, randomized 1:1 to volrustomig plus chemotherapy or pembrolizumab plus chemotherapy.
- mp.weixin.qq.comPickAstraZeneca Stops Late-Stage eVOLVE-Lung02 Trial of Volrustomig Plus Chemotherapy After Failure
AstraZeneca announced it will terminate the late-stage eVOLVE-Lung02 trial, which evaluated volrustomig plus chemotherapy versus pembrolizumab plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer with PD-L1 expression below 50%. The safety profile was consistent with the known profiles of each agent alone, with no new safety signals identified. The company did not specify the reason for termination.
- mp.weixin.qq.comPickAbbVie Registers Phase III NSCLC Trial of ABBV-1480 Versus Pembrolizumab Plus Chemo
AbbVie has registered a Phase III trial (NCT07756645) on ClinicalTrials.gov comparing ABBV-1480 plus chemotherapy against pembrolizumab plus chemotherapy as first-line treatment in 940 patients with locally advanced or metastatic non-small cell lung cancer. ABBV-1480 (RC148) is a PD-1/VEGF bispecific antibody from RemeGen that AbbVie licensed in January for ex-Greater China rights with $650 million upfront and a $5.5 billion total deal value. The trial is expected to start in September 2026 and finish in December 2029, with PFS and OS as primary endpoints.
- x.comNew data at #AACR26:
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