Sone-Ve Cuts Death Risk 42% in Late-Line Gastric Cancer, PFS Endpoint Missed
AZN is trading near its 52-week low of $153.413 (11% above the low).
Summary
AstraZeneca's CLDN18.2-directed ADC sonesitatug vedotin cut the risk of death by 42% versus investigator's choice in 2nd- and later-line CLDN18.2-positive gastric/GEJ cancer, with median overall survival of 10.6 versus 6.4 months (HR 0.58, p<0.000004). In the 3rd-line-plus subgroup the benefit was larger: 53% reduction in risk of death and median OS of 10.0 versus 5.0 months. The catch is progression-free survival by blinded review, a dual primary endpoint, trended better but missed statistical significance (p=0.053), though investigator-assessed PFS showed an HR of 0.59 consistent with the survival data. Tolerability was manageable with fewer Grade 3+ treatment-related adverse events than the comparator (36.4% versus 44.8%). These are first-in-class data for the target and support a broad label covering CLDN18.2 expression at 25% or more of tumor cells; the readout lands alongside a string of positive oncology catalysts for AstraZeneca this quarter, including the September Etcamah FDA approval and DeLLphi-305 survival data. Next data point is the CLARITY-Gastric02 Phase III trial testing Sone-Ve in the 1st-line setting.
At the time of this announcement, AZN was trading at $171.00 on NYSE in the Life Sciences sector, with a market capitalization of approximately $266B. The 52-week trading range was $153.41 to $212.71. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.