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Asset / Drug

Keytruda

Drug and asset intelligence for Keytruda with 30 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
13
Catalysts
17
Stage
Approved

Sponsor company

Merck →

Mechanism of action

KRAS G12C Inhibitor

Recent signals(13)

ClinicalJune 18, 2026

Study Evaluates ePRO Follow-Up for Oncology Patients Post-Hospitalization

The study assesses the feasibility of using electronic patient-reported outcomes (ePRO) and transitional nurse consultations for oncology patients post-discharge.

ClinicalJune 18, 2026

ComboMATCH Trial Targets Genetic Mutations in Advanced Solid Tumors

The ComboMATCH trial aims to match patients with advanced solid tumors to targeted therapies based on genetic testing.

RegulatoryJune 17, 2026

FDA Draft Guidance Aims to Reduce Animal Testing for Cancer Drugs

The FDA has issued draft guidance to minimize unnecessary animal testing in the development of cancer drugs.

ClinicalJune 17, 2026

Lactylation-related biomarker predicts prognosis and therapy response in cutaneous melanoma

A novel lactylation-related prognostic model (CM-LP11) effectively stratifies cutaneous melanoma patients into high- and low-risk groups based on overall survival.

ClinicalJune 17, 2026

Study Reveals Risk Factors for Second Primary Cancer in Colorectal Cancer Survivors

The study identifies age, neoadjuvant therapy, and tumor characteristics as risk factors for second primary cancer in colorectal cancer survivors.

ClinicalJune 17, 2026

Gene Amplification Adjacent to F3 Linked to Poor Outcomes in Pancreatic Adenocarcinoma

Amplification of ARHGAP29 and SLC44A3 genes adjacent to F3 is associated with worse overall and disease-free survival in pancreatic adenocarcinoma.

RegulatoryJune 17, 2026

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

The FDA has granted priority review for KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for muscle-invasive bladder cancer.

ClinicalJune 17, 2026

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

The Phase 3 LITESPARK-012 trial did not meet its dual primary endpoints of progression-free survival and overall survival for the evaluated combination therapies.

RegulatoryJune 16, 2026

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

Calderasib (MK-1084) received Breakthrough Therapy designation for first-line treatment of KRAS G12C-mutant NSCLC.

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.

ClinicalJune 16, 2026

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

Intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death in high-risk melanoma patients.

RegulatoryJune 16, 2026

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

The EU CHMP has issued a positive opinion for the combination of KEYTRUDA and Padcev as a treatment for cisplatin-ineligible muscle-invasive bladder cancer.

RegulatoryJune 13, 2026

FDA Approves KEYTRUDA Combinations for Adjuvant Treatment in Clear Cell RCC

The FDA has approved KEYTRUDA and KEYTRUDA QLEX in combination with WELIREG for adjuvant treatment in ccRCC patients, marking a significant advancement in therapy.

Upcoming milestones(1)

Label Expansion

Merck — Keytruda

Further label stacking extends Keytruda lifecycle amid biosimilar horizon.

July 22, 2026 · Approved

Related catalysts(17)

Label Expansion

Merck — Keytruda

Further label stacking extends Keytruda lifecycle amid biosimilar horizon.

July 22, 2026 · Approved

Topline Data

Merck — KEYTRUDA

Monitor patient enrollment rates and initial outcomes from the trial to assess its impact on treatment paradigms.

June 18, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor trial results for efficacy and safety outcomes, as well as any changes in treatment protocols for sarcomas.

June 18, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor results of the feasibility study and any subsequent implementation of ePRO systems in oncology care.

June 18, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor trial results for efficacy and safety data, as well as subsequent changes in treatment recommendations for NSCLC.

June 18, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor the validation of CM-LP11 in clinical settings and its integration into treatment protocols for cutaneous melanoma.

June 17, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor the PDUFA date of August 17, 2026, for potential approval outcomes and subsequent market reactions.

June 17, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor further analysis of the trial data and any subsequent strategic decisions from Merck and Eisai regarding these therapies.

June 17, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor ongoing research into gene amplification effects on treatment outcomes and potential targeted therapies for pancreatic adenocarcinoma.

June 17, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor trial results for survival outcomes and any changes in treatment guidelines following the trial's completion.

June 17, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor the finalization of the guidance and any subsequent changes in regulatory expectations or industry practices.

June 17, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor developments in surveillance guidelines and potential new therapies targeting second primary cancers in CRC survivors.

June 17, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor upcoming trial results from KANDLELIT-001 and further regulatory developments.

June 16, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor upcoming data releases from ASCENT-04/KEYNOTE-D19 and any regulatory updates regarding intismeran and KEYTRUDA combinations.

June 16, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor upcoming publications and regulatory filings related to intismeran autogene and its combination therapies.

June 16, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor the final approval decision from the European Commission and subsequent market access strategies.

June 16, 2026 · N/A

Topline Data

Merck — KEYTRUDA

Monitor patient uptake, real-world evidence on efficacy, and any competitive responses from other oncology players.

June 13, 2026 · N/A

Indications

Colorectal Cancer →
Endometrial cancer (1L) →
Melanoma →
Pancreatic Adenocarcinoma →

Therapeutic areas

Colorectal Cancer →
Drug Development →
Melanoma →
Oncology →
Pancreatic Adenocarcinoma →
Patient Reported Outcomes →
Solid Tumors →

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