Clinical Trial News

ICMR formalizes MoAs with sponsors for phase 1 clinical trials of four promising molecules, including research on multiple myeloma, Zika vaccine, seasonal influenza vaccine, and CAR-T cell therapy for chronic lymphocytic leukaemia, aiming to establish India as a leader in pharmaceutical agent development.

Early switch to atezolizumab after vemurafenib plus cobimetinib in BRAF V600-positive melanoma showed improved OS at 4 and 5 years in the ImmunoCobiVem trial, but not statistically significant. Rapid progression after switch to immune checkpoint inhibition was observed in some patients.

Adjuvant pembrolizumab (Keytruda) continues to show improved disease-free survival (DFS) vs observation in high-risk muscle-invasive urothelial carcinoma patients after 45 months of follow-up, according to the phase 3 A031501 AMBASSADOR trial. Median DFS was 29.6 months in the pembrolizumab arm vs 14.2 months in the observation arm, with DFS benefits observed regardless of PD-L1 expression and lymph node status.

The HypoG-01 study, led by Dr. Sofia Rivera, shows that a 3-week hypofractionated radiation therapy is equivalent to a 5-week normofractionated therapy for locoregional breast cancer, setting a new standard of care.

Terns Pharmaceuticals (NASDAQ: TERN) could be a lucrative investment for those who missed out on Viking Therapeutics' (NASDAQ: VKTX) 300% surge, as TERN-601, its anti-obesity drug, shows promising phase 1 results and plans to advance to phase 2 in 2025. Terns' stock could mirror Viking's success, with potential for higher upside despite higher risk.

Biomarker-guided selection for nivolumab in MSS/pMMR mCRC could reduce costs and improve efficacy, with lower ICERs in subgroups like those with TMB > 8.0 mut/MB, C-reactive protein < 5.0 mg/L, or target lesion reduction ≥ 10%. This approach could make nivolumab cost-effective in Norway, though validation is needed.

A pembrolizumab regimen significantly improved overall survival (OS) in early-stage triple-negative breast cancer patients, reducing the risk of death by 34% compared to a placebo regimen (HR, 0.66; 95% CI, 0.50-0.87; P = .00150). The 5-year OS rate was 86.6% in the pembrolizumab arm vs 81.7% in the placebo arm.

The phase 3 ENGOT-en11/GOG-3053/KEYNOTE-B21 trial showed no overall DFS improvement with adjuvant pembrolizumab plus chemotherapy, but a significant benefit in DFS for the dMMR subgroup (HR, 0.31; 95% CI, 0.14-0.69). The 2-year DFS rates were 92% and 80% in the pembrolizumab and placebo arms, respectively, for dMMR patients.

Researchers from Queen Mary University of London presented findings at the ESMO Congress 2024, showing that chemotherapy-immunotherapy combinations improve survival in triple-negative breast cancer and muscle-invasive bladder cancer, becoming new standards of care.

Neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab, improved overall survival (OS) by 34% in early-stage triple-negative breast cancer patients, according to KEYNOTE-522 trial data presented at the 2024 ESMO Congress.