Keytruda (pembrolizumab) / Merck (MSD) - LARVOL DELTA

Neoadjuvant Pembrolizumab in Localized Microsatellite Instability High/Deficient Mismatch Repair Solid Tumors. (PubMed, J Clin Oncol) - "Neoadjuvant pembrolizumab in dMMR/MSI-H cancers is safe and resulted in high rates of pathologic, radiographic, and endoscopic response, which has implications for organ-sparing strategies."

Journal • Mismatch repair • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Lenvatinib Plus Pembrolizumab Versus Standard of Care for Previously Treated Metastatic Colorectal Cancer: Final Analysis of the Randomized, Open-Label, Phase III LEAP-017 Study. (PubMed, J Clin Oncol) - P3 | "In patients with pMMR or not MSI-H mCRC that had progressed on previous therapy, there was no statistically significant improvement in OS after lenvatinib plus pembrolizumab treatment versus SOC. No new safety signals were observed."

Journal • Metastases • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Final overall survival for the phase III, KEYNOTE-811 study of pembrolizumab plus trastuzumab and chemotherapy for HER2+ advanced, unresectable or metastatic G/GEJ adenocarcinoma (ESMO 2024) - P3 | "We present results of the final analysis of OS for KEYNOTE-811. Eligible patients (pts) aged ≥18 years with treatment-naive unresectable, HER2+ mG/GEJ adenocarcinoma irrespective of PD-L1 status were randomized 1:1 to pembro 200 mg IV Q3W or pbo IV Q3W plus chemo (5-FU and cisplatin [FP] or capecitabine and oxaliplatin [CAPOX] and trastuzumab [SOC])... First-line pembro plus trastuzumab and chemo provided a statistically significant and clinically meaningful improvement in OS vs pbo plus trastuzumab and chemo in all pts with unresectable, HER2+ mG/GEJ cancer. OS was longer in pts with PD-L1 CPS ≥1. These data support the approval of pembro plus trastuzumab and chemo in pts with HER2+ mG/GEJ cancer and confirm this regimen as SOC in the first-line setting."

Clinical • Metastases • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2 • PD-L1

EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). (ASCO-GU 2025) - P3 | " Pts with previously untreated la/mUC were randomized 1:1 to receive EV (1.25 mg/kg; Days 1 and 8; IV) and P (200 mg; Day 1; IV) or gemcitabine with cisplatin or carboplatin every 3 wks. EV+P continues to demonstrate superior efficacy vs chemo in a broad population, consistent with the primary analysis. Results confirm durable EV+P efficacy with no new safety signals, reinforcing EV+P as SOC for the 1L treatment of pts with la/mUC. Key efficacy and safety outcomes."

Clinical • Combination therapy • Metastases • P3 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Pembrolizumab Versus chemotherapy in microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer: 5-year follow-up from the randomized phase 3 KEYNOTE-177 study. (PubMed, Ann Oncol) - "With >5 years of follow-up, responses to pembrolizumab remained durable. Median OS was over twice as long in patients treated with pembrolizumab versus chemotherapy in first line despite an effective crossover rate of 62%. Pembrolizumab remains a standard of care for MSI-H/dMMR mCRC."

Journal • Metastases • Mismatch repair • P3 data • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Subcutaneous (SC) versus intravenous (IV) pembrolizumab (Pembro) plus chemotherapy (CT) in metastatic non-small cell lung cancer (mNSCLC): Phase III MK-3475A-D77 trial (ELCC 2025) - P3 | "Pembro SC 790 Q6W resulted in pembro exposure and trough concentrations that were noninferior to those of pembro IV 400 mg Q6W, in combination with CT, in pts with mNSCLC. Efficacy was similar in the SC and IV arms. The safety profile of pembro SC plus CT was manageable and consistent with that of pembro IV plus CT."

Metastases • P3 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • ROS1

Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer. (ASCO 2025) - P3 | " Eligible pts received ICI pembrolizumab or sintilimab combined with chemotherapy, as 1st line treatment for stage IIIC-IV NSCLC without driver mutation. In this randomized trial, all three efficacy endpoints of immunochemotherapy were significantly improved through Early vs Late ToD dosing in pts with previously untreated stage IIIC-IV NSCLC. The near doubling in PFS and OS in our trial support the need for further randomized trials to determine the relevance of ToD for ICI efficacy and their underlying circadian mechanisms in pts with various cancer types."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

KEYLYNK-007: Tumor agnostic trial of olaparib plus pembrolizumab in homologous recombination repair mutation- and homologous recombination deficiency- positive advanced cancers (AACR 2025) - P2 | "In this tumor-agnostic trial, olaparib plus pembrolizumab showed promising durable antitumor activity and manageable safety in HRRm and HRD+ (particularly BRCAm) advanced cancers beyond currently approved indications. Biomarker analysis is ongoing for other predictive biomarkers of response.TableBRCA 1/2mN = 132non-BRCA HRRmN = 104non-HRRm HRDN = 96ORR, n (%) [95% CI]36 (27.3) [19.9 - 35.7]12 (11.5) [6.1-19.3]12 (12.5) [6.6-20.8]CR, n (%)11 (8.3)2 (1.9)5 (5.2)PR, n (%)25 (18.9)10 (9.6)7 (7.3)Median DOR mo (95% CI)19.1 (10.7-NR)8.3 (4.2-NR)11.5 (6.2-26.7)15-mo DOR rate, %53.747.641.7Median PFS mo (95% CI)4.4 (4.1-8.2)3.7 (2.3-4.1)4.1 (2.2-5.7)12-mo PFS rate, %31.69.312.0Median OS mo (95% CI)14.0 (11.5, 17.4)10.4 (7.9, 14.6)10.8 (8.3, 15.5)12-mo OS rate, %57.247.147.9CR, complete response; DOR, duration of response; HRRm, homologous recombination repair-mutated; HRD, homologous recombination deficient; mo, months; NR, not reached; ORR, objective response rate; OS,..."

Metastases • Pan tumor • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Leiomyosarcoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Sarcoma • Small Intestinal Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • BRCA • BRCA1 • HRD

Phase 1b/2 study evaluating telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with budigalimab in patients (pts) with advanced non-squamous (NSQ) non-small cell lung cancer (NSCLC) with no prior treatment for advanced disease and no actionable genomic alterations. (ASCO 2025) - P1, P1/2 | "Pts are randomized 1:1:1:1 to Temab-A at 1 of 2 doses determined in part 1 + budigalimab, to budigalimab + CT, or to SOC (pembrolizumab + CT) arms...Treatment continues until disease progression, intolerable toxicity, or other discontinuation criteria are met. The first dosing of the first patient enrolled is planned in March 2025."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. (ASCO 2025) - P3 | " Patients were randomized 1:1 to SG (10 mg/kg IV, day 1 & 8) + pembro (200 mg, day 1, max 35 cycles) in 21-day cycles or chemo (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) + pembro until disease progression or unacceptable toxicity. SG + pembro led to a statistically significant and clinically meaningful improvement in PFS vs chemo + pembro with durable responses, no new safety concerns for SG or pembro, and a lower rate of treatment discontinuation due to TEAEs in patients with previously untreated, PD-L1–positive advanced TNBC. These data support the use of SG + pembro as a potential new standard of care treatment in this patient population."

Clinical • Late-breaking abstract • Metastases • P3 data • Anemia • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • PD-L1

Five-year follow-up results from the phase 3 KEYNOTE-564 study of adjuvant pembrolizumab (pembro) for the treatment of clear cell renal cell carcinoma (ccRCC). (ASCO 2025) - P3 | "With ≥5 yrs of follow-up, the benefits observed with adjuvant pembro vs pbo are consistent with prior analyses, including in all subgroups. No new serious treatment-related safety signals occurred. Adjuvant pembro remains a standard-of-care option for patients with ccRCC at increased risk of recurrence."

Clinical • P3 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Sarcoma • Solid Tumor

Pembrolizumab plus enzalutamide and androgen deprivation therapy versus placebo plus enzalutamide and androgen deprivation therapy for metastatic hormone-sensitive prostate cancer: the randomized, double-blind, phase III KEYNOTE-991 study. (PubMed, Ann Oncol) - "KEYNOTE-991 did not meet its primary end point and was stopped for futility. The addition of pembrolizumab to enzalutamide and ADT was associated with higher frequencies of grade ≥3 AEs and serious AEs than with placebo. Rash was identified as an additional safety signal with pembrolizumab plus enzalutamide and ADT."

Clinical • Journal • P3 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

SUPRAME: A phase 3 trial comparing IMA203, an engineered T-cell receptor expressing T cell therapy (TCR-T) vs investigator's choice in patients with previously treated advanced cutaneous melanoma. (ASCO 2025) - P3 | "Following lymphodepletion with cyclophosphamide (500 mg/m2 x 4 days) and fludarabine (30 mg/m2 x 4 days), 1-10x109 IMA203 TCR-T cells will be administered, followed by low-dose IL-2 (1mio IU daily x5 days, twice daily x5 days). Patients in the control arm will receive approved investigator's choice of standard treatment (nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), chemotherapy)...Secondary endpoints include OS, ORR, safety and patient-reported outcomes (EORTC QLQ-C30, EQ-5D-5L). The trial will enroll patients in the US and Europe."

Clinical • IO biomarker • Metastases • P3 data • Cutaneous Melanoma • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • BRAF • HLA-A • PRAME

Lenvatinib plus pembrolizumab and chemotherapy versus chemotherapy in advanced, metastatic gastroesophageal adenocarcinoma: The phase 3, randomized LEAP-015 study. (ASCO 2025) - P3 | "All pts were randomly assigned 1:1 to induction with pembrolizumab 400 mg IV Q6W (x2) plus oral lenvatinib 8 mg QD and investigators choice chemotherapy (CAPOX Q3W x4 or mFOLFOX6 Q2W x6) then consolidation with pembrolizumab 400 mg Q6W for ≤16 doses plus lenvatinib 20 mg QD (only if 8 mg tolerated for at least 3 weeks), or chemotherapy alone (CAPOX or FOLFOX)... Pembrolizumab plus lenvatinib and chemotherapy vs chemotherapy provided statistically significant improvement in PFS and ORR in pts with advanced unresectable or metastatic gastroesophageal carcinoma at interim analysis. However, there was no significant improvement in OS in pts with PD-L1 CPS ≥1 at final analysis. Safety profiles were consistent with known regimens, with higher AE rates seen in pts receiving the experimental treatment."

Clinical • Metastases • P3 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor • HER-2

Pembrolizumab with chemoradiotherapy in patients with high-risk locally advanced cervical cancer: Final analysis results of the phase 3, randomized, double-blind ENGOT-cx11/GOG-3047/KEYNOTE-A18 study. (ASCO 2025) - P3 | "The CCRT regimen included 5 cycles (with optional 6th dose) of cisplatin 40 mg/m2 Q1W + EBRT then brachytherapy. With an additional 12 mo median follow-up, pembro + CCRT continued to show clinically meaningful improvements in OS and PFS vs pbo + CCRT in pts with high-risk LACC and had a manageable safety profile. These data are consistent with the prior interim analysis and provide further support for pembro + CCRT as the new standard of care for this population. Summary of PFS and OS in ENGOT-cx11/GOG-3047/KEYNOTE-A18.NR=not reached."

Clinical • Late-breaking abstract • Metastases • P3 data • Cervical Cancer • Oncology • Solid Tumor

Phase 3 randomized trial (KEYNOTE-630) of adjuvant pembrolizumab (pembro) versus placebo (pbo) for high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) following surgery and radiation (RT). (ASCO 2025) - P3 | "Pembro did not provide significant benefit in the adjuvant setting for pts with resected, high-risk LA cSCC. The safety profile of adjuvant pembro was consistent with reports from similar studies and there were no treatment-related deaths. The study was stopped for futility as the benefit/risk profile did not support continuing the trial based on recommendations from the data monitoring committee."

Clinical • Metastases • P3 data • Surgery • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Clinical outcomes of the DIET study: A randomized controlled phase 2 trial of a high fiber diet intervention (HFDI) in patients with melanoma receiving immune checkpoint blockade (ICB). (ASCO 2025) - P2 | "ICB regimens include pembrolizumab or nivolumab monotherapy (n = 19), ipilimumab + nivo (n = 16), and nivo + relatlimab (n = 7). Our study suggests potential benefits of HFDI on clinical outcomes and toxicity profile with ICB, warranting further study in Phase III trials powered for disease outcomes."

Checkpoint block • Checkpoint inhibition • Clinical • Clinical data • P2 data • Melanoma • Oncology • Solid Tumor

10-year follow up of a phase 2 clinical trial of pembrolizumab (pembro) in microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) advanced solid tumors. (ASCO 2025) - P2 | "In summary, long term follow up of KEYNOTE-016 confirms high rates of durable remission from pembro in patients with dMMR/MSI-H solid tumors, with several patients remaining alive and in remission at 10+ years follow up. Responses were seen across tumor types. Clinical trial information: NCT01876511."

Clinical • dMMR • Metastases • Mismatch repair • MSI-H • P2 data • Colorectal Cancer • Immunology • Microsatellite Instability • Oncology • Solid Tumor • MSI

BO-112 Plus Pembrolizumab for Patients With Anti-PD-1-Resistant Advanced Melanoma: Phase II Clinical Trial SPOTLIGHT-203. (PubMed, J Clin Oncol) - P2 | "The clinical trial has met its primary end point (ORR) making BO-112 with pembrolizumab a potential strategy to revert anti-PD-1 resistance in patients with MEL. PFS results are in line with other clinical trials in anti-PD-1-resistant scenario, with promising OS data."

Journal • P2 data • Melanoma • Oncology • Solid Tumor

Combination of pembrolizumab and radiotherapy induces systemic antitumor immune responses in immunologically cold non-small cell lung cancer. (PubMed, Nat Cancer) - P2 | "Significant on-therapy expansions of new and pre-existing T cell clones in both the tumor (abscopal) and the blood (systemic) compartments were noted alongside clonal neoantigen-reactive autologous T cell responses in participants with long-term survival after radioimmunotherapy. These findings support the systemic immunomodulatory and antitumor effects of radioimmunotherapy and may open a therapeutic window of opportunity to overcome immunotherapy resistance."

IO biomarker • Journal • Tumor mutational burden • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IFNG • PD-L1 • TMB

Pembrolizumab plus axitinib versus sunitinib for advanced clear cell renal cell carcinoma: 5-year survival and biomarker analyses of the phase 3 KEYNOTE-426 trial. (PubMed, Nat Med) - P3 | "Prospective clinical investigations are needed for biomarker-directed treatment for advanced RCC. ClinicalTrials.gov identifier: NCT02853331 ."

Biomarker • IO biomarker • Journal • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Von Hippel-Lindau Syndrome • BAP1 • PBRM1 • PD-L1 • VHL

Neoadjuvant Pembrolizumab and Accelerated Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Nonurothelial Histologic Subtypes of Muscle-invasive Bladder Cancer: A Phase 2 Trial. (PubMed, Eur Urol) - "These findings suggest that chemoimmunotherapy is a very promising approach for MIBC with histology subtypes. Larger studies are warranted to further refine therapeutic strategies."

IO biomarker • Journal • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Sarcoma • Solid Tumor

Efficacy and Safety of 1L Olomorasib + Chemoimmunotherapy in KRAS G12C-Mutant NSCLC: Results From LOXO-RAS-20001 and SUNRAY-01 (IASLC-WCLC 2025) - "Introduction : Olomorasib, a potent and selective second-generation KRAS G12C inhibitor, demonstrated promising antitumor activity and a manageable safety profile in first-line (1L) KRAS G12C-mutant advanced NSCLC in combination with pembrolizumab plus chemotherapy (chemoimmunotherapy). Moreover, efficacy remains promising in this higher-risk population, largely of pts with PD-L1 0-49%. These updated findings further support the ongoing Phase 3 SUNRAY-01 trial, comparing olomorasib (100 mg BID) plus chemoimmunotherapy versus placebo plus chemoimmunotherapy as 1L treatment in pts with KRAS G12C-mutant NSCLC and any PD-L1 level."

Clinical • IO biomarker • Anemia • Fatigue • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • KRAS • PD-L1

Pembrolizumab Plus Chemotherapy Versus Chemotherapy as Perioperative Therapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer: Final Analysis of the Randomized, Phase III KEYNOTE-585 Study. (PubMed, J Clin Oncol) - P3 | "Participants with previously untreated, locally advanced, resectable gastric and gastroesophageal junction (G/GEJ) cancer were enrolled into the main (n = 804) and fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT; n = 203) cohorts, and randomly assigned 1:1 to neoadjuvant and adjuvant pembrolizumab plus chemotherapy or placebo plus chemotherapy. Pembrolizumab plus chemotherapy continued to show improved outcomes in pathCR and a trend toward longer EFS versus placebo in the main and main plus FLOT cohorts. Efficacy and safety outcomes with perioperative pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab in participants with untreated, locally advanced resectable G/GEJ cancer were consistent with previous analyses."

Journal • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Safety and Efficacy Findings From a Phase Ib/II Study of ASP-1929 Photoimmunotherapy With Pembrolizumab in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. (PubMed, Head Neck) - "ASP-1929 photoimmunotherapy plus pembrolizumab was generally tolerable, with promising efficacy in patients with recurrent/metastatic HNSCC."

Journal • P1/2 data • Gastrointestinal Disorder • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1