Clinical Trial News

Platinum-based therapies are mainstay for endometrial and ovarian cancers but often recur. Antibody drug conjugates (ADCs) like Elahere and datopotamab deruxtecan (Dato-DXd) show promise, with Dato-DXd demonstrating improved outcomes in recurrent EC and OC at ESMO 2024. Dato-DXd's efficacy and safety profile, along with a convenient dosing schedule, position it as a potential preferred treatment over competitors like Merck's sacituzumab govitecan (Sac-TMT), which also shows comparable efficacy in heavily pretreated patients. Both TROP2-directed ADCs offer hope for challenging gynecological cancers.

Alphamab Oncology presented JSKN003's clinical data at ESMO Congress 2024, showing promising efficacy in platinum-resistant ovarian cancer and advanced HER2-positive solid tumors, with favorable safety profiles.

GSK and iTeos presented belrestotug + Jemperli data at ESMO 2024, showing doubled ORR in NSCLC, but lacking survival insights. Belrestotug 400mg is the RP3D for Phase III trial vs. Keytruda. TIGIT inhibitors face competition from Roche, Arcus/Gilead, and AstraZeneca, with market potential of $871m by 2030.

ICMR signs MoAs with industry and academic partners for phase one clinical trials of four new pharmaceutical agents, including a CAR-T cell therapy study for chronic lymphocytic leukaemia, supported by a network of institutions.

Bavarian Nordic’s mpox vaccine added to WHO’s prequalified list.

Exact Sciences' blood-based colon cancer test detected 88.3% of cancers and correctly returned a negative result 90.1% of the time, with 31.2% detection of advanced precancers. This is the first data shared on the test, presented at the European Society for Medical Oncology conference. A larger study is ongoing, with FDA approval expected in the first half of next year.

Pembrolizumab plus chemotherapy in neoadjuvant and adjuvant settings significantly improves OS and pCR rates in high-risk early-stage TNBC, establishing a new standard of care.

TORL-1-23, an ADC targeting CLDN6, shows clinically meaningful responses and manageable safety in CLDN6+ platinum-resistant ovarian cancer patients. A Phase 2 study is planned for registration-enabling, while expansion cohorts in ovarian, NSCLC, and other CLDN6+ cancers continue in the Phase 1 trial.

Incyte's PD-1 inhibitor Zynyz, after initial FDA rejection for SCAC, shows potential in first-line setting with chemo, improving PFS and OS in POD1UM-303 study. Incyte's CDK2 inhibitor INCB123667 shows promise in ovarian cancer, with plans for phase 3 trials starting in 2025.

Simcere Pharmaceuticals' Sanbexin-Sublingualtabletten, an innovative stroke treatment, received Breakthrough Therapy designation from the FDA. This marks the first time the FDA has recognized a breakthrough therapy for stroke treatment. The designation aims to expedite the development and review of drugs for serious conditions, significantly shortening the time for market approval. Clinical trial data showed significant improvements in neurological recovery and self-care ability in AIS patients, published in JAMA Neurology.