Keytruda (pembrolizumab)
/ Merck (MSD)
- LARVOL DELTA
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March 09, 2025
Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China.
(PubMed, Lancet)
- P3 | "Ivonescimab significantly improved PFS compared with pembrolizumab in previously untreated patients with advanced PD-L1 positive non-small cell lung cancer. Therefore, ivonescimab might represent another treatment option in the first-line setting for PD-L1-positive advanced non-small cell lung cancer."
Clinical • IO biomarker • Journal • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ALK • EGFR • PD-L1
August 16, 2025
PEMBROLIZUMAB VS PLACEBO PLUS PACLITAXEL ± BEVACIZUMAB FOR PLATINUM-RESISTANT RECURRENT OVARIAN CANCER: RESULTS FROM THE PHASE 3 ENGOTOV65/KEYNOTE-B96 STUDY
(IGCS 2025)
- P3 | "Efficacy results favored the pembrolizumab arm (Table 1). Subsequent anticancer therapies were used by 52.2% and 60.4% in the pembrolizumab and placebo arms, respectively (Table 2). Grade ≥3 treatment-related adverse events occurred in 67.5% vs 55.3%, respectively."
Clinical • Late-breaking abstract • P3 data • Platinum resistant • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • PD-L1
January 20, 2026
KEYMAKER-U04 substudy 04B: First-line (1L) enfortumab vedotin (EV) plus pembrolizumab (pembro)-based immune checkpoint inhibitor (ICI) combinations for advanced urothelial cancer (UC).
(ASCO-GU 2026)
- P1/2 | " Adult pts without prior systemic therapy for la/mUC and an ECOG PS of 0-1 were randomized 1:1:1 to EV + coformulated favezelimab (fave; anti–LAG3)/pembro 800 mg/200 mg (arm A), EV + coformulated vibostolimab (vibo; anti-TIGIT)/pembro 200 mg/200 mg (arm B), and EV + pembro 200 mg (arm C). In pts with la/mUC, the addition of LAG3- or TIGIT-targeted ICIs to EV + pembro did not have a clinically significant impact on efficacy. No new safety signals were identified. Incidence of certain immune-mediated AEs was higher with pembro-containing coformulations compared to EV + pembro."
Checkpoint inhibition • Clinical • Metastases • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • TIGIT
January 20, 2026
Pathological outcomes and disease-free survival (DFS) in KEYNOTE-905: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible.
(ASCO-GU 2026)
- P3 | "pCR, pDS, surgical outcomes, and DFS favored neoadj-adj EV + pembro and RC + PLND vs RC + PLND alone, supporting the primary results of KEYNOTE-905. These findings further establish neoadj-adj EV + pembro as a potential standard of care for pts with MIBC who are cisplatin-ineligible, addressing a key unmet clinical need. *Not evaluated centrally for pDS due to no available evaluable surgical sample, nonprotocol systemic therapy prior to RC + PLND or operational issues; considered non-pDS in analysis."
Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor
January 20, 2026
Characterization of patients (pts) responding to enfortumab vedotin plus pembrolizumab (EV+P): Exploratory analysis from the phase 3 EV-302 trial of EV+P vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC).
(ASCO-GU 2026)
- P3 | " Pts were randomized 1:1 to receive EV (1.25 mg/kg; D1 and D8, IV) + P (200 mg; D1, IV) or chemo (gemcitabine + cisplatin (cis)/carboplatin). Among pts achieving objective response, PFS and OS were longer in the EV+P arm than in the chemo arm. Durable responses were seen regardless of cis eligibility. Most pts in CR achieved PR before CR, with pts in the EV+P arm converting to CR more rapidly than those in the chemo arm."
Clinical • Metastases • P3 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer
January 20, 2026
Sacituzumab tirumotecan (Sac-TMT) plus pembrolizumab (Pembro) in participants (Pts) with advanced urothelial carcinoma (UC): Results from phase 2 2870-002/SKB264-II-06 study.
(ASCO-GU 2026)
- P2 | "Sac-TMT (MK-2870/SKB264) is a TROP2-directed ADC with a unique bifunctional linker that maximizes delivery of a novel belotecan-derived topo I inhibitor payload to tumor cells, that has shown promising antitumor activity in several tumor types, including as monotherapy in UC (Ye, D, et al...Pts with prior adjuvant or neoadjuvant platinum-based therapy or nivolumab were eligible if they had disease recurrence >12 mo after completing therapy... Sac-TMT + pembro showed promising antitumor activity at both 4 and 5 mg/kg in previously untreated, cisplatin-ineligible pts with la/mUC, with a manageable safety profile consistent with that of the individual treatment components. Further studies are warranted. NE, not estimable; NR, not reached."
Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer
July 11, 2026
Brief Report: First-line Chemoimmunotherapy and Chemotherapy Outcomes in Patients with RET Fusion-Positive Lung Cancer in LIBRETTO-431.
(PubMed, J Thorac Oncol)
- "In patients with advanced RET fusion-positive lung cancer treated in this global, multicenter trial, outcomes with first-line chemoimmunotherapy and chemotherapy were not significantly different in this secondary analysis. Using chemotherapy alone is a reasonable strategy for these oncogene-driven tumors. Based on the overall findings from LIBRETTO-431, selective RET inhibitors remain the preferred first-line therapy for patients with RET fusion-positive NSCLC."
Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • RET
August 19, 2026
Primary Results from Phase 3 EVOKE-03/KEYNOTE D46: Sacituzumab Govitecan + Pembrolizumab in PD-L1 TPS ≥50% Metastatic NSCLC
(IASLC-WCLC 2026)
- P2, P3 | "Conclusions : Despite numerical improvement, SG + pembrolizumab did not meet statistical significance for PFS vs pembrolizumab monotherapy in participants with untreated PD-L1−high mNSCLC; at this interim analysis, OS did not meet statistical significance. The safety profile of SG + pembrolizumab was consistent with the known profiles of each agent, and no new or additional toxicities were observed with the combination."
Late-breaking abstract • Metastases • Alopecia • Hematological Disorders • Immunology • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • ROS1
August 28, 2026
First-Line Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2 -Mutant NSCLC: DESTINY-Lung04 Primary Results
(IASLC-WCLC 2026)
- P3 | "Patients were randomized 1:1 to T-DXd 5.4 mg/kg IV Q3W or pembro 200 mg IV Q3W plus platinum chemo (cisplatin 75 mg/m 2 or carboplatin AUC 5 IV Q3W) and pemetrexed 500 mg/m 2 IV Q3W. Safety was generally consistent with the known profile of T-DXd. These results support T-DXd as a new first-line option for advanced/metastatic HER2 -mutant NSCLC."
Clinical • IO biomarker • Late-breaking abstract • Metastases • Inflammation • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • HER-2
July 31, 2026
A Phase 2 Trial of QLC5508 (MHB088C) Plus QL1706 or QL2107 as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer
(IASLC-WCLC 2026)
- "This study aimed to evaluate the efficacy and safety of QLC5508 in combination with QL1706 (iparomlimab and tuvonralimab, a bifunctional antibody targeting PD-1 and CTLA-4) or QL2107 (a pembrolizumab biosimilar) as first-line treatment in patients with ES-SCLC. Conclusions : QLC5508 in combination with QL1706 or QL2107 as first-line treatment showed promising anti-tumor activity and a manageable safety profile in patients with ES-SCLC. The combined regimen of B7H3 ADC plus PD-1 or PD-1/CTLA-4 antibody is a potential therapy for ES-SCLC and worthy of further exploration."
Clinical • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • CD276
September 10, 2026
Is pembrolizumab as safe and efficient as neoadjuvant treatment in localized dMMR/MSI esophagogastric cancers? Results from the IMHOTEP phase II study.
(PubMed, ESMO Open)
- P2 | "Perioperative pembrolizumab is feasible and safe in localized dMMR/MSI esophagogastric cancers. Further investigation is warranted to optimize the duration and nature of neoadjuvant immunotherapy."
dMMR • Journal • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Microsatellite Instability • Oncology • Solid Tumor • MSI
August 28, 2026
Overall Survival Analysis From HARMONi-2: Ivonescimab vs Pembrolizumab as First-Line Treatment for PD-L1-Positive NSCLC
(IASLC-WCLC 2026)
- P3 | "No new safety signals were identified with ivonescimab relative to the established pembrolizumab safety profile. These findings support ivonescimab as a chemotherapy-free first-line treatment with the potential to redefine the standard of care and serve as a cornerstone of treatment in this patient population."
Clinical • Late-breaking abstract • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • PD-1 • PD-L1
September 11, 2026
Pembrolizumab Plus Chemotherapy for Cervical Cancer: An Exploratory Analysis of the KEYNOTE-826 Randomized Clinical Trial.
(PubMed, JAMA Oncol)
- P3 | "In this exploratory analysis of the KEYNOTE-826 randomized clinical trial, the 5-year data confirm the durability of benefit and reinforce pembrolizumab plus chemotherapy (with or without bevacizumab) as a first-line standard-of-care option for recurrent and metastatic cervical cancer. ClinicalTrials.gov Identifier: NCT03635567."
Clinical • Journal • Cervical Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-L1
July 31, 2026
Real-World Treatment Patterns and Outcomes for BRAFV600E-mutated Metastatic Non-Small Cell Lung Cancer: OCTOPUS Study
(IASLC-WCLC 2026)
- P | "In 1L, 37.3% (n=50) received dabrafenib + trametinib (DT; a BRAF/MEK inhibitor combination), 27.6% received pembrolizumab (P) alone (9.7%; n=13) or with chemotherapy (CT; 17.9%; n=24), 20.1% (n=27) received CT alone, and 14.9% (n=20) received other treatment types. Despite international recommendations, one-third of patients did not receive 1L or 2L BRAF/MEK inhibitor treatment, highlighting the need to optimize therapeutic strategies and treatment sequencing in patients with BRAF V600E mNSCLC. However, no definitive conclusions can be drawn due to the observational nature of this study."
Clinical • HEOR • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
September 17, 2026
Pembrolizumab plus chemotherapy as first-line therapy for advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma: 4.5-year follow-up from the randomized phase III KEYNOTE-859 study.
(PubMed, ESMO Open)
- "Extended follow-up confirms that first-line pembrolizumab plus chemotherapy improves efficacy and maintains a manageable safety profile compared with placebo plus chemotherapy, regardless of PD-L1 status, supporting this combination as a first-line treatment option for locally advanced or metastatic HER2-negative gastric or GEJ adenocarcinoma."
Journal • P3 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2
July 17, 2026
Pembrolizumab or placebo plus concurrent definitive chemoradiotherapy in esophageal and gastroesophageal junction (GEJ) cancer: the Phase 3 randomized KEYNOTE-975 study
(ESMO 2026)
- No abstract available
Clinical • P3 data • Oncology • Solid Tumor
July 17, 2026
Phase 3 LEAP-012 Study of Lenvatinib + Pembrolizumab vs Dual Placebo With Transarterial Chemoembolization (TACE) for Unresectable Non-metastatic Hepatocellular Carcinoma: Long-term OS Results
(ESMO 2026)
- No abstract available
Clinical • Metastases • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor
July 17, 2026
Pembrolizumab with or without platinum-based chemotherapy as first-line treatment in advanced NSCLC with PD-L1 ≥50%: PERSEE phase 3 trial (GFPC 01-2020)
(ESMO 2026)
- No abstract available
Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1
September 22, 2026
INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL)
(ESMO 2026)
- No abstract available
Clinical • Late-breaking abstract • P3 data • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor
September 22, 2026
KEYNOTE-C93/GOG-3064/ENGOT-en15: Phase 3, Randomized, Open-Label Study of First-Line (1L) Pembrolizumab (Pembro) vs Carboplatin (C) + Paclitaxel (P) in Mismatch Repair-Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (a/rEC)
(ESMO 2026)
- No abstract available
Clinical • dMMR • Late-breaking abstract • Metastases • Mismatch repair • P3 data • Endometrial Cancer • Oncology • Solid Tumor
July 17, 2026
Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: randomized phase 3 OptiTROP-Lung06 study
(ESMO 2026)
- No abstract available
Clinical • Late-breaking abstract • Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1
July 17, 2026
Results From KEYNOTE-B49: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab (Pembro) vs Placebo (Pbo) Plus Chemotherapy (CT) in Participants (Pts) With HR+/HER2− Advanced Breast Cancer (ABC)
(ESMO 2026)
- No abstract available
Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2
July 17, 2026
Association of Biomarkers With Efficacy in the Phase 3 KEYNOTE-671 Study of Perioperative Pembrolizumab (Pembro) Plus Neoadjuvant Chemotherapy (Chemo) in Early-Stage Non–Small-Cell Lung Cancer (NSCLC)
(ESMO 2026)
- No abstract available
Biomarker • Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
June 01, 2025
Enfortumab vedotin plus pembrolizumab versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial cancer (EV-302): patient-reported outcomes from an open-label, randomised, controlled, phase 3 study.
(PubMed, Lancet Oncol)
- P3 | "Enfortumab vedotin plus pembrolizumab significantly improved survival outcomes versus platinum-based chemotherapy without detriment to GHS/QOL, pain, or functioning. Patients with moderate to severe baseline pain had clinically meaningful improvements in worst pain and GHS/QOL with enfortumab vedotin plus pembrolizumab. These data provide further evidence to support the use of enfortumab vedotin plus pembrolizumab as a preferred treatment option for patients with previously untreated locally advanced or metastatic urothelial cancer."
Clinical • IO biomarker • Journal • P3 data • Genito-urinary Cancer • Oncology • Pain • Solid Tumor • Urothelial Cancer • PD-L1
July 24, 2025
Phase I study of LY3866288, a potent, highly isoform-selective FGFR3 inhibitor in FGFR3-altered advanced solid tumors (FORAGER-1): Dose optimization
(ESMO 2025)
- P1 | "Preclinically, LY increases nectin 4 cell surface expression and enhances the antitumor activity of enfortumab vedotin (EV) in FGFR3 -altered mUC in vivo models...LY plus EV and pembrolizumab (EVP) is being studied in 1L mUC (B5)...TEAEs associated with poor tolerance and compliance to erdafitinib were uncommon (PPE 7%, onycholysis 0%, retinopathy 0%)...Cohort B5 opened at 200 mg BID and updated data will be presented. Conclusions LY3866288 at 200 mg BID was well-tolerated and demonstrated promising antitumor activity in FGFRi pretreated and naive pts with FGFR3 -altered mUC, warranting further study as monotherapy and combined with EVP."
Metastases • P1 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • FGFR3 • NECTIN4
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