Clinical Trial News

IGNYTE trial data shows RP1 combined with nivolumab has a 33.6% overall response rate in anti-PD1 failed melanoma patients, with 15% complete response rate. Responses were observed in both injected and non-injected tumors, including visceral lesions, and were durable with a median duration of response of 21.6 months. The treatment was well-tolerated with mostly Grade 1-2 adverse events.

SOLARIS trial: High-dose vitamin D3 added to standard chemotherapy plus bevacizumab for metastatic colorectal cancer showed no additional toxicity but did not delay cancer progression more than standard-dose vitamin D3. Potential benefit observed for left-sided disease, requiring further investigation.

Extended follow-up data from the AMBASSADOR trial shows adjuvant pembrolizumab significantly improves disease-free survival in high-risk muscle-invasive urothelial carcinoma (29.6 vs 14.2 months). Benefits are consistent across PD-L1 status and lymph node involvement subgroups, though overall survival analysis is challenging due to unplanned crossover and patient withdrawals. Pembrolizumab's efficacy is seen in both lower and upper tract urothelial cancers, with common metastatic sites including lymph nodes, bone, liver, and lung. The data supports pembrolizumab as a therapeutic option and highlights the need for biomarkers to optimize patient selection.

Scorpion Therapeutics presented initial Phase 1/2 data for STX-478, an oral, mutant-selective PI3Kα inhibitor, at ESMO 2024, showing anti-tumor activity in HR+/HER2- breast cancer, gynecological tumors, and other solid tumors, with potential best-in-class PI3Kα inhibition and minimal wild-type-mediated toxicities.

CL-006 study assessed DAV132's effect on plasma concentration of ATB (CZA, PTZ, CRO) alone or combined at 2 doses. 148 HV randomized, treated with ATB over 5 days alone or with DAV132 over 7 days. Primary objective: assess DAV132's effect on β-lactams plasma concentration. Secondary: safety, interaction on fecal β-lactam excretion. Exploratory: protective effect on intestinal microbiome diversity. Study conducted from May 2019 to Dec 2019 in France under Medical Device regulation.

WHO prequalified MVA-BN as the first mpox vaccine, aiming to boost access and contain outbreaks. Bavarian Nordic plans to supply 10 million doses by 2025. The vaccine is 99.2% effective after two doses, according to CDC data.

MacroGenics presented updated efficacy and safety results from the TAMARACK Phase 2 study of vobramitamab duocarmazine (vobra duo) for mCRPC at ESMO, showing encouraging antitumor activity with 6-month landmark rPFS rates of 69% and 70% in the 2.0 mg/kg and 2.7 mg/kg arms, respectively. Patients remained on vobra duo through a median of 6 doses, and the company expects mature median rPFS data no later than early 2025.

Bristol Myers Squibb presents 10-year CheckMate -067 data showing durable survival benefit with Opdivo plus Yervoy in advanced melanoma, with 43% of patients alive at 10 years, compared to 25% a decade ago. Data published in The New England Journal of Medicine.

Oncternal Therapeutics is discontinuing its phase 1/2 ONCT-808-101 trial for ONCT-808, a CAR-T therapy targeting ROR1 in r/r aggressive B-cell lymphoma, due to capital requirements. ONCT-808 showed antitumor activity and long-term CAR T-cell persistence, but one patient died from shock complications. The company is also halting trials for ONCT-534, zilovertamab, and ONCT-216, and reducing its workforce to explore strategic alternatives.

Apple received FDA approval for AirPods Pro 2's hearing aid feature, enabling users with mild-to-moderate hearing loss to enhance sound clarity without traditional aids. The feature will roll out later this year in over 100 countries.