iOnctura and GSK Collaborate to Advance NSCLC Therapy with Roginolisib Trials
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10 July 2024
iOnctura has announced an expansion of its clinical trial program for roginolisib, focusing on non-small-cell lung cancer (NSCLC) in collaboration with the ETOP IBCSG Partners Foundation and GSK. The Phase II study will evaluate the combination of roginolisib with dostarlimab, and possibly docetaxel, targeting NSCLC resistant to initial therapies.
This initiative marks a significant stride in cancer research, particularly for patients with NSCLC resistant to first-line therapies. Roginolisib, an innovative allosteric modulator of PI3Kδ, acts as a critical regulator in the cancer signaling pathway, offering a new mechanism to attack tumor cells and bolster immune response.
Dostarlimab, a PD-1 inhibitor previously approved for certain types of endometrial cancer, has shown promise in NSCLC in combination with chemotherapy. Under the collaboration, GSK will supply dostarlimab for the trials. Meanwhile, iOnctura retains global rights to roginolisib, emphasizing their leadership in its development.
Catherine Pickering, CEO of iOnctura, expressed enthusiasm about the trials: "We are thrilled to be able to assess the effectiveness of roginolisib in combination with dostarlimab for the treatment of NSCLC. The successful uveal melanoma data reported so far, combined with a rich preclinical data package, support the rationale to expand our development program with potentially synergistic combinations in NSCLC.”
The ETOP IBCSG Partners Foundation, renowned for its international cancer research, will facilitate access to a network of top-tier investigators across Europe, spearheaded by Professor Solange Peters from the University Hospital of Lausanne.
Prof. Solange Peters highlighted the potential of this combination therapy: "In patients who no longer respond to current therapies, we wish to investigate whether roginolisib in combination with dostarlimab provides a novel treatment option. ETOP IBCSG Partners Foundation is committed to investigate novel treatment options to help our patients.”
About Roginolisib
Roginolisib has carved a niche as the first allosteric modulator of PI3Kδ with a unique structure that targets one of the most commonly disrupted pathways in cancer. With a favorable safety profile demonstrated in clinical trials, particularly in rare cancers like uveal melanoma, roginolisib represents a beacon of hope. The planned randomized Phase II trials, expected to commence in late 2024, will further assess its potential in NSCLC and other cancer types.
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