The GSK-licensed drug showed an overall survival benefit versus topotecan in advanced or relapsed small-cell lung cancer, with global Phase III development ongoing. This is the first positive Phase III survival data for a B7-H3 ADC.
Hansoh Pharma has announced positive Phase III results for risvutatug rezetecan, also known as Ris-Rez, an investigational lung cancer treatment licensed by GSK outside Greater China.
The ARTEMIS-008 trial was conducted in China and focused on patients with advanced or relapsed small-cell lung cancer, meaning the cancer had spread or returned after treatment. The study met its primary endpoint of overall survival, showing that patients treated with Ris-Rez lived longer than those given topotecan, a standard chemotherapy used after small-cell lung cancer comes back.
Small-cell lung cancer is a fast-growing and aggressive form of lung cancer. Many patients initially respond to treatment, but the disease often returns.
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The results are the first positive Phase III overall survival data reported for a B7-H3-targeted antibody-drug conjugate in any tumor type.
Ris-Rez is an antibody-drug conjugate, a targeted cancer treatment that links a monoclonal antibody to a cancer-killing drug payload. B7-H3 acts like a marker on the cancer cell, while the antibody helps deliver the payload inside.
The antibody is designed to recognize B7-H3, a protein found at high levels in several cancers, including small-cell lung cancer.
In addition to the survival benefit, the trial showed consistent benefit across key secondary endpoints, including progression-free survival (PFS), which measures how long patients live without their disease getting worse.
No new safety signals were reported, meaning the trial did not identify unexpected safety concerns compared with what had already been seen in earlier studies.
Hansoh plans to use the ARTEMIS-008 results to support regulatory submissions in China.
GSK gained exclusive rights to develop and commercialize the drug outside mainland China, Hong Kong, Macau and Taiwan through a licensing agreement with Hansoh Pharma in 2023.
The company is now studying Ris-Rez globally across several solid tumors, including lung cancer and prostate cancer. Its program includes EMBOLD SCLC-301, a global Phase III trial in relapsed extensive-stage small-cell lung cancer, with pivotal data expected next year.
Ris-Rez has also received several regulatory designations, including FDA Breakthrough Therapy Designations in small-cell lung cancer and osteosarcoma, as well as Orphan Drug designation for small-cell lung cancer in Japan.
GSK has also been expanding its lung cancer portfolio. Its $10.6 billion Nuvalent acquisition in June added three non-small cell lung cancer assets, including late-stage ROS1 and ALK inhibitors already under FDA review. GSK said the deal would accelerate its entry into lung cancer and support expansion alongside Ris-Rez.
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