Clinical Trial News

Pembrolizumab (Keytruda) showed improved survival over ipilimumab (Yervoy) in stage III/IV melanoma patients, with 10-year OS rates of 34% vs 23.6% and MSS rates of 45.2% vs 31.3%. Pembrolizumab's median OS was 32.7 months vs 15.9 months for ipilimumab, and median modified PFS was 9.4 months vs 3.8 months. Patients who responded well to initial pembrolizumab treatment had significant long-term benefits, with 80% OS rate after 94 weeks of treatment. These results support pembrolizumab as a standard care for advanced melanoma.

Maintenance olaparib plus cediranib did not significantly improve PFS or OS vs olaparib alone in relapsed platinum-sensitive ovarian cancer patients, according to the phase 3 ICON9 study. Median PFS was 11.0 months vs 13.9 months, and median OS was 37.8 months vs 37.2 months, with no statistical significance. Safety profiles were consistent with expected toxicities.

The phase 3 IKF-AIO-RAMTAS trial found no significant OS improvement with ramucirumab + TAS-102 vs TAS-102 alone in heavily pretreated mCRC patients, though benefits were seen in female patients and those with left-sided tumors. The combination showed improved PFS and DCR but increased hematotoxicity and dose reductions.

Johnson & Johnson announced Phase 2b SunRISe-1 study results showing TAR-200's 83.5% complete response rate in BCG-unresponsive HR-NMIBC patients, with 82% maintaining response after 9 months.

Enhertu demonstrated superior efficacy in treating HER2+ breast cancer brain metastases at ESMO 2024, outperforming Kadcyla. Enhertu's 12-month PFS was 61.6% with an ORR of 79% for CNS metastases, maintaining 90.3% OS in active BCBM patients. Analysts predict Enhertu will dominate the ADC market, reaching $11.2bn by 2030, while Kadcyla and Tukysa are projected to achieve $838m and $1.2bn respectively.

YL201, a B7H3-targeting ADC, showed encouraging antitumor activity in SCLC (ORR 68.1%, mPFS 6.2 months), NPC, and wild-type NSCLC in Phase I studies. Presented at ESMO 2024, YL201 is developed on MediLink’s TMALIN® platform.

Neoadjuvant immunotherapy significantly improves 5-year relapse-free survival in stage IIIB or greater melanoma patients, with major pathological response (MPR) showing the highest benefit. Neoadjuvant ICI therapies yield the highest MPR rates and 3-year event-free survival, outperforming BRAF/MEK targeted therapies. Patients achieving MPR have a 3-year relapse-free survival above 85%, while those without it only 40%. Overall survival is over 80% for all treatment groups, with MPR patients achieving 97-100% 3-year OS compared to 70% for non-response patients.

Allison Watkins, an Edmond woman, created Yni.Fit, an insertion device for urinary incontinence, after failing to find a suitable solution for her condition. After clinical trials and FDA approval, she launched the product in Oklahoma this summer, with plans to go national next year.

GSK and iTeos' anti-TIGIT antibody belrestotug, combined with GSK's PD-1 inhibitor Jemperli, showed higher objective response rates in PD-L1-positive NSCLC patients in the GALAXIES Lung-02 study, though with higher discontinuation rates and treatment-related deaths. The 400mg dose is moving to phase 3 trials.

NIAGARA Phase III trial results show AstraZeneca's IMFINZI (durvalumab) in combination with chemotherapy significantly improves event-free survival (EFS) and overall survival (OS) in muscle-invasive bladder cancer (MIBC) patients, compared to neoadjuvant chemotherapy alone.