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NRG-GY020: Phase III randomized trial of radiation +/- MK-3475 (pembrolizumab) for newly diagnosed early-stage high intermediate risk (HIR) mismatch repair deficient (dMMR) endometrioid endometrial cancer
https://esmocongress.esmo.org
ESMO Congress 2026
October 23–27, 2026 · Madrid · 2949 items
pembrolizumab
★★★48 people · 52 posts · 8 abstracts
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Heat now 7·Peak in the comparable set 8 (Oct 25 00:00)·Change over 24h in the comparable set –·Participants now 11
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Deep dive
The evidence base for the PD-1 antibody pembrolizumab rests on pivotal phase 3 trials: KEYNOTE-024 compared pembrolizumab with investigator's-choice platinum-based chemotherapy in previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells, with median PFS of 10.3 vs 6.0 months [1], after which pembrolizumab monotherapy replaced cytotoxic chemotherapy as the first-line treatment of choice in the PD-L1 ≥50% population [5]; KEYNOTE-189 evaluated pemetrexed plus a platinum with pembrolizumab or placebo in metastatic nonsquamous NSCLC without sensitizing mutations, with OS and PFS as primary endpoints [5], extending earlier evidence that the combination produced higher response rates and longer PFS than chemotherapy alone [5]. The two strategies ran in parallel, and the head-to-head comparison of monotherapy versus combination within the PD-L1 ≥50% population is exactly the question PERSEE set out to answer.
At ESMO 26, the GFPC phase 3 PERSEE trial (01-2020) provided a direct answer: 321 patients with previously untreated advanced NSCLC and PD-L1 ≥50% were randomized in an open-label design to pembrolizumab plus platinum-based chemotherapy or pembrolizumab alone, with PFS by blinded central review as the primary endpoint, presented by Chantal Decroisette. Median PFS was 16.1 vs 6.9 months, HR 0.56 (0.43–0.74), p<0.001; ORR 77.5% vs 50.3%; median OS 50.2 vs 29.9 months, HR 0.77 (0.57–1.05) — a notable numerical difference that was not statistically significant, and several commentators on site noted that OS was not the primary endpoint; the trade-off was grade ≥3 treatment-related AEs of 53.8% vs 19.3%.
Relative to existing knowledge, PERSEE shifts the PD-L1 ≥50% population away from a default of monotherapy toward stratified decisions based on tumor burden, pace of disease, comorbidities and biomarkers: adding chemotherapy does deliver deeper and faster disease control, but grade ≥3 toxicity nearly triples, turning the question from whether to add into for whom to add, which is consistent with earlier whole-exome sequencing data linking mutation and neoantigen burden to sensitivity to PD-1 blockade [3]. Note also that the 6.9-month median PFS of PERSEE's monotherapy arm and the 10.3 months in KEYNOTE-024 [1] come from different trials, so cross-trial comparison warrants caution.
Several other pembrolizumab readouts at the same meeting should not be conflated with the PERSEE mainline: the final phase 2 IOV-COM-202 showed lifileucel plus pembrolizumab in checkpoint inhibitor-naïve advanced melanoma with ORR 62.5%, CR 29.2%, median PFS 19.8 months and mDOR not reached, with 13/15 responses lasting ≥12 months, and the phase 3 TILVANCE-301 to advance the signal; neoHIP showed adding pembrolizumab to neoadjuvant THP raised pCR from 48.3% to 67.2% (+18.9%, p=0.03) in early HER2+ breast cancer; another trial found pembrolizumab plus dCRT did not improve EFS or OS in esophageal/GEJ cancer even with PD-L1 CPS ≥10; and data on the personalized mRNA vaccine intismeran autogene plus pembrolizumab reducing melanoma recurrence were also reported. Limitations: PERSEE was open-label, OS was neither the primary endpoint nor statistically significant, and criteria for selecting patients for whom the toxicity is worthwhile remain to be defined.
References
- 1.Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer · N Engl J Med 2016
- 2.PD-1 Blockade in Tumors with Mismatch-Repair Deficiency · N Engl J Med 2015
- 3.Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer · Science 2015
- 4.PD-1 blockade induces responses by inhibiting adaptive immune resistance · Nature 2014
- 5.Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer · N Engl J Med 2018
- 6.Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial · Lancet 2016
Evidence
Sacituzumab tirumotecan (Sac-TMT) + pembrolizumab (Pembro) in post-platinum advanced mismatch repair proficient (pMMR) endometrial cancer (EC)
https://esmocongress.esmo.org2071O
STARBOARD phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini), and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma
https://esmocongress.esmo.org2072O
Efficacy and safety of lifileucel and pembrolizumab in patients with immune check point inhibitor-naïve advanced melanoma: Final results from IOV-COM-202 study
https://esmocongress.esmo.org2217RONCT04746300
Updated results from the phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) + carboplatin and etoposide chemotherapy (chemo) or chemo alone for neuroendocrine prostate cancer (NEPC)
https://esmocongress.esmo.org2683P
First-line (1L) olomorasib + pembrolizumab in KRAS G12C-mutant NSCLC: Updated results from LOXO-RAS-20001 and SUNRAY-01
https://esmocongress.esmo.org2875O
Pembrolizumab or placebo plus concurrent definitive chemoradiotherapy in esophageal and gastroesophageal junction (GEJ) cancer: The phase 3 randomized KEYNOTE-975 study
https://esmocongress.esmo.org3609P
Adjuvant pembrolizumab plus belzutifan versus placebo in clear cell renal cell carcinoma: A reconstructed survival data analysis of the KEYNOTE-564 and the LITESPARK-022 trials
https://esmocongress.esmo.orgFloor
mp.weixin.qq.com BioNTech 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.
Same topic pembrolizumab · 82 peopleNo engagement yetclinicaltrials.gov Reduction of Neoadjuvant Treatment in Early Triple-Negative Breast Cancer
Same topic pembrolizumab · 58 peopleNo engagement yetNEJM Adjuvant 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.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.com NMPA 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 OncologyPick Tumour 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.
Why it matters: Phase IIA evidence that neutrophil and gut microbiota features track response to AXL-PD1 inhibition in mesothelioma.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick AK112 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.
Why it matters: First OS win over pembrolizumab in a phase 3 lung cancer trial for a Chinese-developed drug.
Cancer Discovery Intratumoral Sotigalimab with Pembrolizumab Induces Rapid Activation of Antigen-Presenting Cells and Drives Antitumor Responses in Non-injected Tumors in Metastatic Melanoma: A Phase I/II Study
mp.weixin.qq.comPick Moderna 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.
Why it matters: Reports the positive INTerpath-001 topline readout and Moderna's 177% share surge as a market reference for personalized mRNA neoantigen therapy in melanoma adjuvant treatment.
Same topic pembrolizumab · 58 peopleNo engagement yetbiocentury.comPick Moderna, 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.
Why it matters: The positive Phase III data validate personalized neoantigen vaccines in melanoma adjuvant therapy and inform extending the mRNA platform to oncology.
mp.weixin.qq.comPick AstraZeneca 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.
Why it matters: Head-to-head miss for volrustomig versus pembrolizumab gives a direct negative control for PD-1/CTLA-4 bispecifics in first-line lung cancer.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick AbbVie 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.
Why it matters: Head-to-head Phase III data against pembrolizumab will test a $5.5 billion licensing bet.
clinicaltrials.gov A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Same topic pembrolizumab · 82 peopleNo engagement yetclinicaltrials.gov US/PA/E Imaging for Early Identification of Tumor Response in Patients With Stage II-III Triple Negative Breast Cancer Receiving Neoadjuvant Immunotherapy and Chemotherapy
Same topic pembrolizumab · 58 peopleNo engagement yetclinicaltrials.gov Labyrinthin Vaccination in Veterans With Lung Adenocarcinoma
Same topic pembrolizumab · 58 peopleNo engagement yetSci AdvPick Once 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.
Why it matters: It shows a single implant can deliver monoclonal antibodies for months to a year, replacing repeated injections.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick NMPA 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.
Why it matters: First subcutaneous PD-1 inhibitor approval in China affects a top-selling oncology drug's delivery options.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.com NMPA 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.
Same topic pembrolizumab · 58 peopleNo engagement yetbioRxiv Cancer BiologyPick Tissue 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.
Why it matters: Identifies a T-cell subset that predicts checkpoint inhibitor response and survival in glioblastoma.
Same topic pembrolizumab · 58 peopleNo engagement yetJAMA Vaccines for Cancer: A Translational Science Review.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick Moderna 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.
Why it matters: The article links the phase III randomized results to the vaccine's technical route of up to 34 neoantigens, LNP delivery, and epitope spreading.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick Moderna 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.
Why it matters: INTerpath-001 met both RFS and DMFS in adjuvant melanoma, informing head-to-head comparison of individualized neoantigen mRNA therapy with PD-1 monotherapy adjuvant.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick Merck 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.
Why it matters: The source reports adjuvant RFS and DMFS results that can serve as a benchmark for mRNA neoantigen therapy in solid-tumor adjuvant settings.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick AstraZeneca 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.
Why it matters: The head-to-head failure against first-line pembrolizumab rules out volrustomig replacing or adding to standard therapy in this population.
Same topic pembrolizumab · 58 peopleNo engagement yetmp.weixin.qq.comPick AstraZeneca 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.
Why it matters: The brief gives trial design, enrollment size and randomization; the bispecific's failure here can be compared with readouts from similar bispecifics.
Same topic pembrolizumab · 58 peopleNo engagement yet