Clinical Trial News

Luveltamab tazevibulin (luvelta) + bevacizumab showed 56% ORR in late-stage ovarian cancer at RP2D, with 35% overall response rate. No new safety signals were observed. Expansion at RP2D ongoing with 23 additional patients enrolled; data expected in H1 2025.

Updated MARIPOSA-2 study results show amivantamab plus chemotherapy significantly improves post-progression outcomes and overall survival in previously treated NSCLC patients with EGFR exon 19 deletions or L858R mutations, compared to chemotherapy alone.

Express Pharma, India’s leading business fortnightly for the pharmaceutical industry since 1994, covers news, analysis, and interviews in segments: Market, Management, Research, and Pharma Life. It also publishes periodic specials like Pharma Technology Review and Packaging Special.

RP1 (vusolimogene oderparepvec) combined with nivolumab (Opdivo) showed durable antitumor activity and a favorable safety profile in advanced melanoma patients who progressed on anti–PD-1 therapy, with a 33.6% overall response rate and a 15.0% complete response rate. The median duration of response was 21.6 months, and most treatment-related adverse events were grade 1 or 2. A phase 3 trial, IGNYTE-3, is underway to further evaluate this combination.

SPRINT and ACCORD-BP trials pooled for post-hoc analysis; SPRINT tested intensive BP control (SBP < 120 mmHg) vs. standard (SBP < 140 mmHg) in high CVD risk non-DM participants, while ACCORD-BP used a 2x2 factorial design in high CVD risk DM participants. Outcome of interest was stroke-free survival (SFS), analyzed using Kaplan-Meier curves and Cox proportional hazards models. Data available at https://biolincc.nhlbi.nih.gov.

Novavax's 2024-2025 Formula COVID-19 vaccine, the only protein-based option in the U.S. for individuals aged 12 and older, is now available at major pharmacy retailers nationwide. The vaccine targets the JN.1 variant and has received Emergency Use Authorization from the FDA.

Interim Phase I data of mRNA-4359 immunotherapy shows promise in advanced solid cancers, with 8/16 patients showing no tumor growth. The therapy activates immune response and is well-tolerated, supporting further research.

Kura Oncology (KURA) is a clinical-stage biopharmaceutical company developing precision medicines for cancer, with key candidates like Tipifarnib, Ziftomenib, and KO-2806. Recent achievements include preliminary data from the KOMET-007 trial and securing financing through 2027.

FDA approves Roche’s Tecentriq Hybreza, the first subcutaneous anti-PD-(L) cancer immunotherapy, offering greater treatment flexibility with consistent safety and efficacy.

FDA decision deadlines include Vanda's tradipitant for gastroparesis (Sept 18), Zevra's arimoclomol for Niemann-Pick disease type C (Sept 21), Heron's extended-release needle for Zynrelef (Sept 23), Merck's Keytruda for pleural mesothelioma (Sept 25), and Bristol Myers Squibb's KarXT for schizophrenia (Sept 26). Sanofi and Regeneron await FDA verdict on Dupixent for COPD (Sept 27).