Keytruda is the brand name for pembrolizumab, a human PD-1 blocking antibody used across a broad range of cancers. It is approved in multiple tumor types and biomarker-defined settings, including melanoma, lung, head and neck, gastrointestinal, gynecologic, and urothelial cancers. The FDA first approved Keytruda in 2014.
BioNTech faces mixed analyst views as Bernstein initiates with a cautious Market Perform rating, while the company secures FDA Fast Track designation for BNT113 and prepares for a shareholder vote on capital restructuring and leadership transition.
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
TuHURA Biosciences said the FDA granted orphan drug designation to IFx-2.0 for stage IIB to stage IV cutaneous melanoma based on Phase 1 data. The company said its Phase 3 IFx-2.0 study in first-line Merkel cell carcinoma continues to enroll.
Microgravity drug research is expanding from ISS crystal studies to commercial manufacturing efforts. New experiments and a Varda-United Therapeutics collaboration target improved drug stability, delivery and production.
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
The FDA approved Keytruda and Keytruda Qlex with paclitaxel, with or without bevacizumab, for PD-L1-positive platinum-resistant ovarian-related cancers. The Phase III KEYNOTE-B96 trial showed improved progression-free and overall survival versus placebo.
Merck received FDA approval in early February 2026 for KEYTRUDA and KEYTRUDA QLEX in PD-L1-positive platinum-resistant ovarian cancer. The decision marks the first approval of a PD-1 inhibitor regimen for this setting.
Deutsche Bank upgraded Merck to Buy and raised its price target to $150 from $115, citing a clear path beyond Keytruda’s patent expiration. Merck meanwhile forecast 2026 revenue of $65.5 billion to $67.0 billion and said it faces a $2.5 billion headwind this year.
The ASCENT-04 trial shows Trodelvy plus Keytruda extends progression-free survival by 3.4 months in PD-L1-positive metastatic triple-negative breast cancer. Meanwhile, the ToPCourT trial investigates trilaciclib combined with pembrolizumab and chemotherapy for advanced TNBC. These developments signal evolving treatment approaches for this aggressive breast cancer subtype.
Adagene and Incyte will collaborate on a Phase 1 study combining muzastotug with INCA33890 for MSS colorectal cancer patients, beginning in 2026. The collaboration marks the second instance where Adagene's SAFEbody technology is paired with a PD-1-based bispecific. Muzastotug has shown encouraging response rates in combination with pembrolizumab in previous trials.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07475572 |
A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07388550 |
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I) |
NOT_YET_RECRUITING | PHASE1 |
| NCT07122687 |
IBI363 Combined With Chemotherapy or Pembrolizumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer |
RECRUITING | PHASE2 |
| NCT06643117 |
Similar Efficacy, Safety, and Immunogenicity of FYB206 in Comparison to Keytruda as add-on to Chemotherapy in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) |
TERMINATED | PHASE3 |
| NCT06551064 |
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06472583 |
Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer |
RECRUITING | PHASE2 |
| NCT06400160 |
Clinical Trial of TB511 in Advanced Solid Tumors |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06348199 |
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05986331 |
Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma |
UNKNOWN | PHASE3 |
| NCT05849480 |
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC) |
RECRUITING | PHASE1/PHASE2 |
