GSK lung cancer drug cuts death risk by 54% in pivotal trial

GSK ↗ 5.03% reported on Sunday that its cancer drug risvutatug rezetecan, known as Ris-Rez, reduced the risk of death by 54% compared with standard treatment in patients with relapsed small cell lung cancer, results that sent the company's shares higher at the start of trading on Monday.

Trial Results

The data come from the ARTEMIS-008 Phase III trial conducted in China, which enrolled 461 patients whose disease had progressed after platinum-based chemotherapy. After a median follow-up of 12.2 months, patients receiving Ris-Rez lived a median of 18.5 months, compared with 10.3 months for those on topotecan, the current standard second-line treatment. The hazard ratio was 0.46, meaning Ris-Rez nearly halved the risk of death (p<0.0001).iaslc+1

Ris-Rez also showed advantages across secondary measures. Median progression-free survival was 7.2 months versus 3.0 months for topotecan, the objective response rate was 58.3% versus 12.6%, and the disease control rate was 90.4% versus 60.2%. Severe treatment-related side effects occurred in 60.9% of Ris-Rez patients compared with 78.2% for topotecan.proactiveinvestors+1

The results mark the first time a Phase III trial has demonstrated a survival benefit for a therapy targeting B7-H3, a protein found on tumor cells, in any cancer type.oncodaily+1

What It Means for GSK

Ris-Rez belongs to the antibody-drug conjugate class, which pairs an antibody with a cancer-killing agent to deliver treatment directly to tumor cells. GSK licensed the drug from Hansoh Pharmaceutical Group and holds exclusive rights to develop and sell it outside mainland China, Hong Kong, Macau, and Taiwan.global.morningstar+1

Hesham Abdullah, GSK's senior vice president and global head of oncology R&D, said the survival improvement and safety data "provide further momentum for GSK's global development of Ris-Rez across later-line and earlier treatment settings for small cell lung cancer".global.morningstar

GSK's own global Phase III trial, EMBOLD SCLC-301, is currently enrolling patients with relapsed extensive-stage small cell lung cancer and is expected to deliver pivotal data in 2027.proactiveinvestors+1

Market Reaction

GSK shares rose in early Monday trading on the FTSE 100, with the stock among the session's top performers on the London index. The broader healthcare sector also saw a modest lift, which analysts attributed to a read-across from the trial results. The gains came on a day when the FTSE 100 opened higher despite headwinds from weaker commodity prices and renewed concerns about AI investment and elevated oil prices.investing