Clinical Trial News

Scemblix® (asciminib), with a unique STAMP mechanism, offers a new treatment for CML patients in Europe resistant or intolerant to prior TKIs. The CHMP's positive opinion, based on Phase III ASCEMBL trial data, shows Scemblix nearly doubles MMR rates and significantly lowers discontinuation due to adverse reactions compared to Bosulif®.

FDA granted accelerated approval to Novartis’s dabrafenib and trametinib combo for treating BRAF V600E mutation-positive unresectable or metastatic solid tumors in patients aged 6+ with no satisfactory alternatives. Novartis shares slightly dropped to CHF78.23, with a 12-month target of CHF90.75.

FDA approved Novartis' Tafinlar and Mekinist combo for advanced solid tumors with BRAF V600E mutation, following prior therapy progression and no alternatives. Approved for various cancers, including pediatric use, based on trials showing up to 80% response rates in some tumors.

This article reviews the progress in clinical trials of oncolytic viruses (OVs) for cancer treatment, highlighting their safety, effectiveness, and the challenges faced in their development. OVs selectively infect and kill cancer cells without harming normal cells, showing promise in treating various tumors with mild adverse events.

The FDA's draft guidance on ctDNA for early-stage solid tumor drug development outlines its use as a biomarker in clinical trials for patient selection, enrichment, response measurement, and as an early endpoint. It emphasizes the importance of assay validation and encourages sponsors to consult the FDA for regulatory uses of ctDNA.

DBV Technologies has announced positive topline results from its Phase 3 EPITOPE trial, evaluating the safety and efficacy of Viaskin Peanut in treating peanut-allergic toddlers aged 1 to 3 years. The trial met its primary endpoint, showing a significant treatment effect with 67.0% of subjects in the Viaskin Peanut arm meeting response criteria at 12 months, compared to 33.5% in the placebo arm.

The FDA approved Fylnetra, a biosimilar to Neulasta, for treating febrile neutropenia in cancer patients undergoing chemotherapy. Developed by Amneal Pharmaceuticals and Kashiv Biosciences, it marks the fifth pegfilgrastim biosimilar approval in the US. Amneal plans to launch Fylnetra, Releuko, and Alymsys in 2022.

Risankizumab, an IL-23 p19 inhibitor, showed efficacy and safety in treating moderately to severely active Crohn's disease in phase 3 trials ADVANCE and MOTIVATE. Patients receiving risankizumab achieved higher clinical remission and endoscopic response rates at week 12 compared to placebo, with similar adverse event rates across groups.

Uliledlimab shows safety and efficacy in NSCLC, with CD73 expression linked to clinical response. A Phase 3 study in NSCLC is planned for 2023. I-Mab to host an investor call on May 27, 2022, to discuss findings.

FDA approved ivosidenib with azacitidine for untreated IDH1-mutated AML, based on AGILE trial showing improved EFS and OS. The combo has a known safety profile, marking a significant advancement for patients unsuitable for intensive chemotherapy.