Merck — Pharmaceutical Intelligence | Humanexa Signals

CompetitiveJune 16, 2026

Merck Reports Promising Long-Term Data for KEYTRUDA and Intismeran in Oncology at ASCO 2026

Five-year follow-up data from KEYNOTE-942 show the potential of intismeran autogene in combination with KEYTRUDA for high-risk melanoma. Additionally, KEYNOTE-522 results indicate a continued survival benefit for high-risk early-stage TNBC patients.

Recent signals(65)

Merck initiates long-term study on Sotatercept for Pulmonary Arterial Hypertension

FDA Accepts NDA for IDVYNSO Containing Doravirine and Islatravir

Merck's Bomedemstat Trial for Polycythemia Vera Aims to Improve Treatment Outcomes

Merck's Access Plans for Alimatravir in HIV PrEP Targeting Low-Income Countries

Merck's MK-1045 Under Investigation for Non-Hodgkin Lymphoma Treatment

Patritumab Deruxtecan Study Initiated for Advanced Gastrointestinal Cancers

FDA Accepts Supplement for STEGLUJAN (Ertugliflozin/Sitagliptin)

FDA Accepts Supplement for STEGLATRO (Ertugliflozin) by Merck

Merck's Sotatercept Study for Pulmonary Arterial Hypertension Launches in India

Merck's MK-2214 Trial Aims to Slow Tau Spread in Early Alzheimer's Disease

FDA Grants Approval for Enlicitide by Merck Sharp and Dohme

Merck's Pembrolizumab Study Targets Japanese Pediatric and Adult Cancer Patients

Merck's LIPFENDRA Approved as First Oral PCSK9 Inhibitor for Hypercholesterolemia

Merck to Present New Data on HIV Treatment Options at AIDS 2026

KEYTRUDA Shows Significant PFS Improvement in dMMR Endometrial Cancer in Phase 3 Trial

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

FDA grants priority review for KEYTRUDA supplemental application

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

Merck's MK-1403 Trial Targets Type 2 Diabetes and hsCRP Levels

FDA Approves KEYTRUDA and KEYTRUDA QLEX for Muscle-Invasive Bladder Cancer

Merck's Sacituzumab Tirumotecan in TNBC Shows Potential in Combination with Pembrolizumab

FDA Approves Pembrolizumab Combinations for Muscle Invasive Bladder Cancer

Merck and Daiichi Sankyo Launch ESCC Combination Therapy Study with Pembrolizumab

FDA Accepts NDA for IDVYNSO Containing Doravirine and Islatravir

Phase II Trial of Pembrolizumab and Trastuzumab in HER2-positive Esophagogastric Adenocarcinoma

Merck's MK-2870 Study Targets Advanced Gastrointestinal Cancers

Merck Partners with ADAP to Enhance Access to IDVYNSO for HIV Treatment

Merck's MK-1045 Combined with Rituximab in Follicular Lymphoma Trial Launched

FDA Accepts Supplemental Application for KEYTRUDA QLEX

FDA Approves Supplement for KEYTRUDA (pembrolizumab) by Merck

FDA Approves KEYTRUDA and Trodelvy Combination for First-Line TNBC Treatment

European Commission Approves KEYTRUDA Plus Padcev for Cisplatin-Ineligible Bladder Cancer

Intismeran Autogene Plus Pembrolizumab Trial for NSCLC Initiated by Merck and Moderna

Merck's Enlicitide Study Aims to Enhance LDL-C Reduction with Rosuvastatin

Merck's Sac-TMT Trial for Advanced Ovarian Cancer Aims to Improve Maintenance Treatment Outcomes

Merck's Tulisokibart Achieves Key Endpoints in Phase 3 UC Study

Merck's Pimicotinib Study Targets Tenosynovial Giant Cell Tumor in Japan

FDA approves belzutifan with pembrolizumab for renal cell carcinoma treatment

FDA Grants Priority Review for Welireg Supplement from Merck

FDA Approves CAPVAXIVE for At-Risk Children and Adolescents

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

FDA Grants Priority Review for Welireg Supplement NDA215383

Phase III Trial Evaluates Pembrolizumab Timing in NSCLC Treatment

Phase III Trial of Pembrolizumab Plus Doxorubicin in Aggressive Sarcomas

Nemtabrutinib Study vs Ibrutinib/Acalabrutinib in 1L CLL/SLL Initiated

Zilovertamab Vedotin Shows Promise in rrDLBCL with Standard Care in Phase 2/3 Study

Phase III Trial of Pembrolizumab with Chemotherapy in Non-small Cell Lung Cancer

Merck's Acquisition of Terns Pharmaceuticals Advances as HSR Waiting Period Expires

Merck's ENFLONSIA Approved in EU for RSV Prevention in Infants

FDA Grants Priority Review for KEYTRUDA and KEYTRUDA QLEX in MIBC Treatment

FDA Approves Merck’s IDVYNSO for Virologically Suppressed HIV-1 Patients

Merck and Eisai's LITESPARK-012 Trial Fails to Meet Primary Endpoints in RCC

Calderasib and Pembrolizumab Study in KRAS G12C NSCLC Shows Promising Efficacy

NeoAdjuvant Therapy Trial for TNBC: Sacituzumab Govitecan + Pembrolizumab

Merck Acquires Terns Pharmaceuticals, Enhancing Oncology Pipeline with TERN-701

Merck Receives FDA Approval for IDVYNSO, Expands Oncology Pipeline and Animal Health Sales

Merck Acknowledges Daiichi Sankyo's ADC Manufacturing Update

Merck Publishes Method for Scalable Synthesis of Oral PCSK9 Inhibitor Enlicitide Decanoate

FDA Grants Breakthrough Therapy Designation for Calderasib in KRAS G12C-Mutant NSCLC

Merck Reports Promising Long-Term Data for KEYTRUDA and Intismeran in Oncology at ASCO 2026

5-Year Data Shows Intismeran Autogene + KEYTRUDA Reduces Melanoma Recurrence Risk by 49%

Merck's KEYTRUDA Plus Padcev Receives Positive EU CHMP Opinion for Muscle-Invasive Bladder Cancer

Merck's Sacituzumab Tirumotecan Shows OS and PFS Improvement in Endometrial Cancer Phase 3 Trial

Merck and Gilead Discontinue Phase 3 Study of Trodelvy and KEYTRUDA in NSCLC

FDA Approves KEYTRUDA Combinations for Adjuvant Treatment in Clear Cell RCC

Upcoming catalysts(1)

Merck — Keytruda

Regulatory activity(26)

FDA Accepts NDA for IDVYNSO Containing Doravirine and Islatravir

FDA Accepts Supplement for STEGLUJAN (Ertugliflozin/Sitagliptin)

FDA Accepts Supplement for STEGLATRO (Ertugliflozin) by Merck

FDA Grants Approval for Enlicitide by Merck Sharp and Dohme

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

FDA grants priority review for KEYTRUDA supplemental application

FDA Grants Priority Review for KEYTRUDA QLEX Supplement Application

FDA Approves KEYTRUDA and KEYTRUDA QLEX for Muscle-Invasive Bladder Cancer

FDA Approves Pembrolizumab Combinations for Muscle Invasive Bladder Cancer

FDA Accepts NDA for IDVYNSO Containing Doravirine and Islatravir

FDA Accepts Supplemental Application for KEYTRUDA QLEX