Hutchmed Limited

HUTCHMED announces positive SAVANNAH Phase II trial results showing TAGRISSO® (osimertinib) plus ORPATHYS® (savolitinib) effective for MET-driven resistance in EGFR-mutated lung cancer, with high ORR and durability.

Osimertinib plus savolitinib combo shows high, durable ORR in EGFR-mutant, MET-overexpressed/amplified NSCLC patients progressing on osimertinib, per SAVANNAH trial. Safety profile consistent with known profiles; no new safety signals. Detailed results to be presented and submitted for regulatory review. FDA granted fast track designation in 2023.

HUTCHMED announces positive results from SAVANNAH Phase II trial showing TAGRISSO® (osimertinib) plus ORPATHYS® (savolitinib) effective for MET-driven resistance in EGFR-mutated NSCLC, with high ORR and durability.

HUTCHMED announced positive SAVANNAH Phase II trial results showing TAGRISSO plus ORPATHYS had a high, clinically meaningful ORR for EGFRm NSCLC patients with MET overexpression/amplification, whose disease progressed on TAGRISSO. The combination received Fast Track designation from the FDA in 2023. ORPATHYS, an oral MET TKI, is jointly developed by AstraZeneca and HUTCHMED, and approved in China for NSCLC with MET exon 14 skipping alterations. The safety profile of TAGRISSO plus ORPATHYS was consistent with known profiles. The global SAFFRON Phase III trial will further assess this combination versus platinum-based doublet chemotherapy.

SAVANNAH Phase II trial shows TAGRISSO® (osimertinib) plus ORPATHYS® (savolitinib) effective for EGFRm NSCLC with MET overexpression/amplification, with high ORR and durability.

Global cancer cases surge, with a 79% rise in new cases among patients under 50. The highest death tolls are linked to breast, windpipe, lung, bowel, and stomach cancers. Cancer rates are projected to increase by 77% by 2050. In response, biotech firms like Oncolytics, AbbVie, BeiGene, HUTCHMED, and Enliven Therapeutics are accelerating treatment innovations, with the FDA approving 16 new oncology treatments in 2024. Oncolytics plans to submit a clinical trial for breast cancer treatment to the FDA in early 2025.

DelveInsight's 'Breast Cancer Pipeline Insight 2024' highlights a robust pipeline with 100+ companies developing 120+ drugs, driven by rising incidence, tech advancements, and increased awareness. Key companies and drugs include Ambrx, CSPC ZhongQi, Merus, and ARX788, DP303c, SHR-A1811, among others. FDA fast-track designations and breakthrough therapy designations for drugs like 9MW2821 and inavolisib underscore significant progress.

AstraZeneca's Tagrisso (osimertinib) approved in the US for treating unresectable, Stage III EGFRm NSCLC, reducing disease progression risk by 84% compared to placebo. The approval is based on the LAURA phase III trial results, showing a median PFS of 39.1 months with Tagrisso versus 5.6 months for placebo. The trial continues to assess overall survival.

FDA approves AstraZeneca's Tagrisso for unresectable, Stage III EGFR-mutated lung cancer, based on LAURA Phase III trial results showing 84% reduction in disease progression risk.