Business
BridgeBio Pharma Announces First Lung Cancer Patient Dosed in Phase 1/2 Trial and US FDA Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with Amgen’s LUMAKRAS® (sotorasib)
- BBP-398, an investigational SHP2 inhibitor, is a potentially optimal agent for use in combination therapies given its continuous, once-daily dosing in
About this update from Bridgebio Pharma, Inc.
[{"type":"text","content":"- BBP-398, an investigational SHP2 inhibitor, is a potentially optimal agent for use in combination therapies given its continuous, once-daily dosing in addition to synergistic activity with other agents to treat cancers driven by KRAS G12C mutations - The combination of investigational therapy BBP-398 and LUMAKRAS, if successful, has the potential to address the serious unmet need for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). - This combination trial is designed to target NSCLC driven by a KRAS G12C mutation, one of the most common oncogenic mutations in the United States (US) and European Union (EU); 13% of NSCLC tumors have a KRAS G12C mutation with approximately 30,000 people diagnosed in the US each year - Preclinical findings demonstrated synergistic efficacy for the combination of the two therapies in a KRAS G12C-mutated NSCLC cell line-derived xenograft model PALO ALTO, Calif., Oct. 11, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc., (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first patient with non-small cell lung cancer (NSCLC) has been dosed in its Phase 1/2 clinical trial of BBP-398, an investigational SHP2 inhibitor, with Amgen Inc.’s (Amgen) LUMAKRAS® (sotorasib), the first and only currently approved targeted treatment for patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, in advanced solid tumors with the KRAS G12C mutation. Approximately 30,000 people are diagnosed with KRAS G12C-mutated NSCLC in the US each year and the KRAS G12C mutation is one of the most frequent oncogenic mutations in the US and Europe. By combining SHP2 inhibition with KRAS G12C inhibition in patients with the KRAS G12C mutation, there is potential to prevent oncogenesis and overactive cellular proliferation. “The survival rate following a diagnosis of NSCLC with a KRAS mutation is extremely poor. We are hopeful that by launching this clinical trial with Amgen, we may be able to fill the current gap in unmet medical need for these cancer patients,” said Frank McCormick, Ph.D., chairman of oncology at BridgeBio. “We are grateful the FDA has granted our program Fast Track designation and are hopeful it will allow us to address the needs of these patients more quickly following diagnosis.” The Phase 1/2 ...