Also known as: Keytruda Qlex, KEYTRUDA QLEX
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.
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.
Two studies show liquid biopsy can predict immunotherapy response in HER2-negative breast cancer and identify which patients with relapsed germ cell tumors may benefit from high-dose chemotherapy, advancing precision oncology.
Recent biosimilar and biologic developments included Health Canada approval of denosumab biosimilars, FDA review actions, and new licensing and commercialisation agreements. Other updates covered court, trial and reimbursement agenda decisions.
A 12-week supervised remote exercise program for patients with metastatic renal cell carcinoma undergoing immunotherapy showed significant improvements in health-related quality of life, fatigue, and symptom burden in a case series of 19 patients.
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.
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.
FDA has cleared a robotic nipple-sparing mastectomy platform after clinical trials showed excellent results with preserved breast sensation. Researchers are advancing immunotherapy combinations for breast cancer and novel strategies to overcome drug resistance in EGFR-mutated lung cancer, including protein degraders and dual-binding inhibitors.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07594015 |
Pembrolizumab and Lenvatinib in Mismatch Repair Proficient Recurrent Endometrial Cancer After Failure of First-Line Therapy With Platinum-based Doublet and Immunotherapy |
RECRUITING | PHASE2 |
| NCT07591597 |
A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07578649 |
Symbiotic-GYN-18: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Advanced or Recurrent MMR-proficient Endometrial Cancer |
NOT_YET_RECRUITING | PHASE3 |
| NCT07572123 |
Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07566156 |
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer ( EV-309 ) |
RECRUITING | PHASE3 |
| NCT07565285 |
The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07552558 |
Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC) |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07541170 |
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC) |
NOT_YET_RECRUITING | PHASE3 |
| NCT07524257 |
Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC |
NOT_YET_RECRUITING | PHASE3 |
| NCT07523763 |
Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer |
ACTIVE_NOT_RECRUITING | PHASE2 |
