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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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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
David H Aggen, MD PhD@Dr_Aggen MeDucation@MeDucationai 引用@A major step. Could combining blood and urine tumour DNA with bladder assessment help us identify who can safely avoid surgery without compromising cure? @myESMO #ESMO26 @Uromigos
Oncology Learning Network@OncLearnNetwork Same topic pembrolizumab · 48 people#INTISMERAN#PEMBROLIZUMAB#MELANOMA24 views0 likes0 reposts0 repliesMartin ZapataLaguado@zapatalaguadomd #ESMO26 | EV + pembrolizumab in cisplatin-eligible MIBC.
Andrey Soares@SoaresAndrey Just as we did with adjuvant pembrolizumab in kidney cancer #ESMO26
medicalxpress.com A precision T-cell therapy stalls treatment-resistant cancers in clinical trial
Same topic pembrolizumab · 48 peopleNo engagement yetmp.weixin.qq.com INTerpath-001 Phase 3 Positive While BNT113 Plus Pembrolizumab Misses on PFS, Splitting mRNA Cancer Vaccine Results
Clinical results for mRNA cancer vaccines are diverging. The Phase 3 INTerpath-001 trial read out positive, while BNT113 combined with pembrolizumab failed to significantly improve PFS in first-line treatment.
NaturePick Moderna mRNA vaccine almost halves the risk of skin cancer returning
A 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 in each patient's tumor and did not increase major serious side effects. Experts consider the magnitude of risk reduction clinically meaningful, but long-term efficacy and the populations that benefit require further analysis.
Why it matters: The brief provides the key 42% risk-reduction figure, letting readers assess the clinical significance of a personalized mRNA vaccine plus immunotherapy in preventing post-surgical melanoma recurrence.
Same topic pembrolizumab · 58 peopleNo engagement yetbiocentury.comPick Moderna’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% in a Phase III melanoma trial (HR=0.58, p<0.001), validating the benefit of personalized vaccines in adjuvant therapy. The article notes the therapy faces challenges from manufacturing complexity, 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.
Why it matters: The article notes the personalized cancer vaccine significantly outperformed adjuvant Keytruda but commercialization still faces high costs, manufacturing complexity and competition from neoadjuvant immunotherapy strategies.
Same topic pembrolizumab · 82 peopleNo engagement yetmp.weixin.qq.comPick Detailed 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%.
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.
Same topic pembrolizumab · 58 peopleNo engagement yetFDA DrugsPick FDA 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.
Why it matters: The TMB-H threshold rises from 10 to 13 mut/Mb because efficacy in patients with 10 to under 13 mut/Mb was insufficient.
Same topic pembrolizumab · 82 peopleNo engagement yetclinicaltrials.gov Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
clinicaltrials.gov Immune Checkpoint Blockade and Chemotherapy With or Without Fecal Microbiota Transplant in Advanced Non-Small Cell Lung Cancer
clinicaltrials.gov Optimizing Response to Immunotherapy With Online Adaptive Pulsed Radiotherapy in Incurable Head and Neck Cancers
Same topic pembrolizumab · 58 peopleNo engagement yetclinicaltrials.gov Pulsed Stereotactic Ablative Radiotherapy (PULSAR) With Systematic Therapy for Thyroid Cancer
clinicaltrials.gov Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study.
medRxiv Oncology Does 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.
clinicaltrials.gov PD-1 Blockade Alone Versus in Combination With Chemotherapy as First Line Therapy in Females With Advanced NSCLC & PD-L1 Expression ≥50%
Same topic pembrolizumab · 82 peopleNo engagement yetclinicaltrials.gov A Clinical Trial Comparing an Antibody (INCA33890) Versus Pembrolizumab for Squamous Cell Carcinoma of the Head and Neck.
Same topic pembrolizumab · 82 peopleNo engagement yetmp.weixin.qq.com BNT113 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.
Same topic pembrolizumab · 82 peopleNo engagement yetmp.weixin.qq.comPick Ivonescimab 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.
Why it matters: First head-to-head survival win over pembrolizumab in frontline PD-L1-positive advanced lung cancer.
Same topic pembrolizumab · 48 peopleNo engagement yetmp.weixin.qq.comPick BioNTech 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.
Why it matters: First phase 3 failure for a BioNTech mRNA cancer vaccine candidate in a key indication.
Same topic pembrolizumab · 82 peopleNo engagement yetmedRxiv Oncology USFDA Oncology Drug Approvals from 2014- 2025: Comparing non-immunotherapy and immunotherapy approvals, their endpoints, and their efficacy.
Same topic pembrolizumab · 82 peopleNo engagement yetbiocentury.comPick Merck and Moderna’s melanoma vaccine data bring adoption test into focus
Adding Merck and Moderna's intismeran autogene to 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.
Why it matters: Places the 42% reduction in recurrence or death risk alongside personalized manufacturing complexity, cost, and pre-surgical immunotherapy competition.
Same topic pembrolizumab · 82 peopleNo engagement yetclinicaltrials.gov Becotatug Vedotin in Combination With Immunotherapy and Multimodality Radiotherapy for Esophageal Squamous Cell Carcinoma in the Second-line or Later Setting
Same topic tislelizumab · 7 peopleNo engagement yetyoutube.com A 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.
Same topic pembrolizumab · 82 peopleNo engagement yetreddit.com ESMO 2026: 15 Trials That May Change Treatment Practice
Same topic pembrolizumab · 58 peopleNo engagement yetFDA Drugs Other | 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.
Same topic pembrolizumab · 82 peopleNo engagement yetFDA Drugs Verified 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.
Same topic pembrolizumab · 82 peopleNo engagement yetmp.weixin.qq.com FDA 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.
Same topic pembrolizumab · 82 peopleNo engagement yet