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Pembrolizumab news
All news on
Pembrolizumab
(also known as
KEYTRUDA
): plants, production capacities, investments and involved companies.
8 June 2026
Merck and Gilead discontinue Phase 3 KEYNOTE‑D46/EVOKE‑03 (Trodelvy + KEYTRUDA) in PD‑L1 ≥50% mNSCLC
eDMC recommended stopping the Phase 3 trial after final PFS and interim OS reviews: PFS trend non‑significant, OS unlikely to be significant; safety profile consistent; ~620 patients enrolled.
1 June 2026
Moderna & Merck: 5‑Year Data — Intismeran plus KEYTRUDA Reduces Recurrence in High‑Risk Resected Stage III/IV Melanoma
5-year Phase 2b follow-up: combination showed 49% RFS reduction (HR 0.51), 59% DMFS reduction (HR 0.411); OS trend (HR 0.471). Safety consistent; increased neoantigen-specific T‑cell clonotypes
29 May 2026
Merck: FDA Grants Breakthrough Designation to Calderasib (MK‑1084) for First‑Line KRAS G12C‑Mutant Metastatic NSCLC
Supports calderasib plus pembrolizumab in PD‑L1 ≥1% newly diagnosed metastatic KRAS G12C NSCLC; positive Phase 1 KANDLELIT‑001 data; multiple Phase 3 trials planned; developed with Taiho/Astex
30 April 2026
Merck & Co Q1 2026 Results — Sales Growth, Regulatory Approvals and Clinical Milestones
Q1 revenue $16.3B; KEYTRUDA $8.0B. GAAP loss $1.72/sh, non-GAAP loss $1.28/sh after $9.0B Cidara charge. Announced Terns acquisition; raised 2026 sales to $65.8-67.0B and non-GAAP EPS $5.04-5.16
28 February 2026
Merck's KEYTRUDA and WELIREG Combo Reduces RCC Recurrence Risk by 28%
Phase 3 trial shows KEYTRUDA and WELIREG improve disease-free survival in RCC. FDA accepts priority review for adjuvant treatment. Safety profile consistent with previous studies.
27 February 2026
Merck's KEYTRUDA and Padcev Cut Event-Free Survival Risk by 47% and Mortality by 35% in Cisplatin-Eligible Bladder Cancer Patients
KEYTRUDA plus Padcev improves survival and reduces recurrence in muscle-invasive bladder cancer, showing potential as a new standard for cisplatin-eligible patients.
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27 February 2026
Merck's KEYTRUDA Plus Paclitaxel Boosts Survival in Platinum-Resistant Ovarian Cancer
KEYTRUDA plus paclitaxel improves overall survival in platinum-resistant ovarian cancer, regardless of PD-L1 status, as shown in the KEYNOTE-B96 trial.
18 February 2026
Johnson & Johnson's RYBREVANT FASPRO™ Gains FDA Breakthrough Status for Advanced Head and Neck Cancer
FDA grants Breakthrough Therapy Designation to RYBREVANT FASPRO™ for HPV-unrelated head and neck cancer after platinum-based chemotherapy and PD-1/PD-L1 inhibitor.
12 February 2026
Merck Presents New Data on Bladder and Kidney Cancer Treatments at 2026 ASCO GU Symposium
New data shows improved survival rates for bladder and kidney cancer treatments, highlighting advancements in Merck's oncology portfolio at the ASCO GU Symposium.
11 February 2026
Merck's KEYTRUDA and KEYTRUDA QLEX Approved for PD-L1+ Platinum-Resistant Ovarian Cancer
FDA approves KEYTRUDA regimens for platinum-resistant ovarian cancer, showing reduced disease progression and death risk in trials.
3 February 2026
Merck Announces Q4 and Full-Year 2025 Financial Results, Highlights Pipeline Progress
Strong oncology and animal health sales, positive trial results, and strategic acquisitions drive growth. 2026 outlook projects sales up to $67B, with EPS impacted by acquisition charges.
20 January 2026
Moderna and Merck Report 5-Year Data on Intismeran Autogene with KEYTRUDA
Intismeran autogene with KEYTRUDA shows 49% reduced risk of recurrence or death in high-risk melanoma over five years. Further data to be presented at a future medical conference.
7 January 2026
Merck Launches Phase 3 Trial of Calderasib with KEYTRUDA QLEX for Advanced NSCLC
Merck's KANDLELIT-007 trial tests calderasib and KEYTRUDA QLEX for KRAS G12C-mutant NSCLC, focusing on progression-free survival and overall response.
17 December 2025
Merck's KEYTRUDA and Padcev Enhance Survival in Cisplatin-Eligible MIBC Patients
KEYTRUDA and Padcev improve survival and response rates in MIBC patients, showing promise as perioperative treatment with consistent safety profiles.
21 November 2025
Merck's KEYTRUDA and Padcev Approved by FDA for Bladder Cancer Treatment
FDA approves first PD-1 inhibitor plus ADC regimens for cisplatin-ineligible muscle-invasive bladder cancer, based on KEYNOTE-905 trial results showing significant EFS improvement.
19 November 2025
Merck's KEYTRUDA® Subcutaneous Form Approved by European Commission
KEYTRUDA SC, a subcutaneous immune checkpoint inhibitor, is approved in Europe for faster administration across all adult indications.
30 October 2025
Merck Announces Q3 2025 Financial Results
Sales rose 4% to $17.3B. KEYTRUDA up 10%, GARDASIL down 24%. GAAP EPS $2.32, Non-GAAP $2.58. FDA approved KEYTRUDA QLEX. Acquired Verona Pharma. Full-year sales outlook: $64.5B-$65B.
29 October 2025
Merck and Eisai Update on LEAP-012 Trial for Hepatocellular Carcinoma
The LEAP-012 trial showed no overall survival benefit for the treatment, but progression-free survival improved. The study is closed, and further data analysis is ongoing.
29 October 2025
Merck's KEYTRUDA Approved in EU for Treating Resectable LA-HNSCC
KEYTRUDA gains EU approval as the first anti-PD-1 therapy for resectable LA-HNSCC with PD-L1 expression, based on KEYNOTE-689 results.
28 October 2025
Merck's KEYTRUDA and WELIREG Combo Improves DFS in RCC Patients Post-Nephrectomy
The LITESPARK-022 trial shows improved DFS with KEYTRUDA and WELIREG in RCC patients. Safety profiles align with previous studies. Results to be shared with regulators.
28 October 2025
Merck and Eisai's WELIREG and LENVIMA Improve PFS in Advanced Renal Cell Carcinoma Trial
The trial showed significant PFS and ORR improvements with WELIREG and LENVIMA in advanced RCC patients post anti-PD-1/L1 therapy, with consistent safety profiles.
23 October 2025
Merck's KEYTRUDA and KEYTRUDA QLEX Get FDA Priority Review for Bladder Cancer Treatment
FDA grants priority review for KEYTRUDA combinations with Padcev, showing improved survival in muscle-invasive bladder cancer patients ineligible for cisplatin-based chemotherapy.
19 October 2025
Johnson & Johnson's Subcutaneous Amivantamab Shows 45% Response Rate in Head and Neck Cancer
Subcutaneous amivantamab offers rapid, durable responses in head and neck cancer, with 82% tumor shrinkage and a median response duration of 7.2 months.
18 October 2025
Merck and Eisai: KEYTRUDA and LENVIMA Show 5-Year Survival Benefit in Advanced Endometrial Carcinoma
KEYTRUDA and LENVIMA improve 5-year survival rates in advanced endometrial carcinoma compared to chemotherapy, with consistent results across patient subgroups.
18 October 2025
Merck's KEYTRUDA Plus Chemotherapy Reduces Disease Progression Risk in Platinum-Resistant Ovarian Cancer
KEYTRUDA with chemotherapy shows significant survival benefits in platinum-resistant ovarian cancer, leading to FDA priority review for expanded use.
18 October 2025
Merck: KEYTRUDA and Padcev Cut Bladder Cancer Risks Pre- and Post-Surgery
KEYTRUDA and Padcev improve survival rates in muscle-invasive bladder cancer patients ineligible for cisplatin, showing significant event-free and overall survival benefits.
16 October 2025
Merck's KEYNOTE-B96 Trial Shows Improved Survival in Platinum-Resistant Ovarian Cancer
The trial showed improved overall survival with KEYTRUDA in platinum-resistant ovarian cancer, with consistent safety and no new signals. Results to be presented at a future medical meeting.
9 October 2025
Merck Showcases Oncology Advances at ESMO 2025
Merck presents positive data on KEYTRUDA and other investigational medicines for various cancers, highlighting progress in treatment and research at ESMO 2025.
19 September 2025
FDA Approves Merck's Subcutaneous KEYTRUDA QLEX for Solid Tumors
KEYTRUDA QLEX, a subcutaneous immune checkpoint inhibitor, offers comparable efficacy to IV KEYTRUDA in treating metastatic NSCLC, with administration possible in one minute by healthcare providers.
