Also known as: Keytruda Qlex, 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.
Moderna and Merck's personalized mRNA cancer vaccine, intismeran autogene, showed promising Phase 3 results in preventing melanoma recurrence. Combined with Keytruda, it cut recurrence risk by half and reduced spread by 59% in earlier data. The treatment could reach patients within two years pending regulatory approval.
The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
Blockbuster drugs worth hundreds of billions face generic competition as patents expire through 2032. Indian drugmakers could capture $3-5 billion of the opportunity, while GSK and Bristol Myers Squibb prepare for revenue losses.
Candel initiated the Phase 3 AURORA trial of aglatimagene in NSCLC and plans a Q4 2026 BLA in localized prostate cancer, with a potential 2027 launch. The company also appointed a Chief Commercial Officer.
KEYNOTE-942 five-year data: intismeran autogene plus Keytruda reduced melanoma recurrence risk by 49% and kept 68.8% of patients cancer-free versus 49.1% with Keytruda alone. Distant metastasis or death risk fell 59%.
The FDA approved six cancer therapies in Q2 2026, including first-line sacituzumab govitecan for triple-negative breast cancer and capivasertib for PTEN-deficient prostate cancer. A separate study shows 69% of accelerated-approval cancer drugs need safety updates within 4 years.
Intensity Therapeutics restarted its INVINCIBLE-4 Phase 2 trial of INT230-6 in presurgical triple-negative breast cancer, reporting 71.4% pCR with INT230-6 plus SOC versus 33% with SOC alone. 2025 cash stood at $11.9M with runway into Q2 2027.
Four biomarkers—MMR, HER2, PD-L1, and Claudin 18.2—are now validated for advanced esophageal cancer, guiding immunotherapy and targeted treatment decisions. Checkpoint inhibitors show clear benefit in MSI-H and PD-L1-positive subgroups, with long-term survival observed. NCCN guidelines recommend broad testing to personalize therapy.
Atezolizumab plus capecitabine showed no significant survival benefit in residual TNBC. Other reports covered HER2-low AR enrichment, first-line ADC choices, and a self-management planner.
A phase 2 trial showed neoadjuvant pembrolizumab achieved a 71% pathological complete response rate in resectable desmoplastic melanoma. A real-world study found ipilimumab monotherapy after anti-PD-1 progression yielded an ORR of 10.8% and median OS of 7.6 months in advanced melanoma.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07783581 |
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07777822 |
Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC |
RECRUITING | PHASE3 |
| NCT07773987 |
Immunotherapy and Nodal-Sparing Irradiation for T-Cell Induction and Unmasking of Tumor Antigenicity in the Microenvironment for Head and Neck Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07770100 |
Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07765433 |
Testing the Addition of Ivonescimab Combined With Standard Chemotherapy Compared to the Usual Chemotherapy and Immunotherapy Treatment for Patients With Advanced Biliary Tract Cancer |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07762716 |
Combination Immunotherapy Treatment for Glioblastoma Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07762703 |
Combination Immunotherapy Treatment for Locally Advanced Unresectable or Metastatic, PD-L1 Negative (CPS<10), gBRCA Negative, Triple Negative Breast Cancer Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07756645 |
A Study to Assess Intravenous ABBV-1480 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First Line Treatment of Locally Advanced/Metastatic Non-Small Cell Lung Cancer in Adult Participants |
NOT_YET_RECRUITING | PHASE3 |
| NCT07749586 |
A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
| NCT07744126 |
A Study to Assess Adverse Events, Change in Disease Activity and Optimal Dose of Intravenous (IV) Telisotuzumab Adizutecan With IV Pembrolizumab for First-Line Treatment of Adult Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma |
NOT_YET_RECRUITING | PHASE2 |
