Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer assets in late-stage development.
The FDA has signed off on GSK’s ROS1 inhibitor zidesamtinib, one of the main bounties from its recent multibillion buy of Nuvalent Bio, for certain types of lung cancer. The drug will carry the brand name Jideytro.
Jideytro is indicated for patients with advanced non-small cell lung cancer (NSCLC) who are positive for the ROS1 gene fusion—a particular mutation that triggers uncontrolled cell growth—and who have undergone a prior line of ROS1-directed therapy. The regulatory win represents GSK’s market entry into lung cancer, according to a Wednesday announcement.
The approval also delivers a quick return on GSK’s $10.6 billion acquisition of Nuvalent Bio, which was announced in June and closed last week. The buyout is among the industry’s largest of the year so far. In addition to zidesamtinib, the acquisition gave GSK the ALK blocker neladalkib. That asset is currently under FDA review for NSCLC, with an approval decision expected by Nov. 27.
Jideytro—and neladalkib, if approved—both have “multi-blockbuster potential,” GSK said in its news release announcing the Nuvalent deal back in June. Around 50,000 people globally are diagnosed with ROS1-positive NSCLC every year, the pharma added on Wednesday, many of whom are non-smokers in middle-age “who could stay on treatment for several years.”
Data from the Phase 1/2 single-arm ARROS-1 clinical trial supported Jideytro’s approval, demonstrating an overall response rate of 44%. Duration of response rate was 82% at six months and 69% at 12 months. The drug showed “meaningful and durable responses” even in Patients with brain metastases and ROS1 resistance mutations, according to GSK.
Aside from Jideytro and neladalkib, GSK gained a third NSCLC drug candidate from Nuvalent dubbed NVL-330. The asset is in early-stage development for HER2-altered NSCLC, with enrollment currently ongoing for a Phase 1a/1b study, according to a federal trials database.
The Nuvalent-acquired assets join GSK’s Hansoh Pharmaceutical–partnered antibody-drug conjugate (ADC) risvutatug rezetecan (ris-rez), which the collaborators are also advancing for NSCLC. Data from the Phase 3 ARTEMIS-008 trial earlier this month showed significantly better overall survival outcomes in patients on ris-rez versus standard of care. These findings have emboldened Hansoh to seek approval for ris-rez in China.
GSK paid $185 million upfront in December 2023 for the license to develop and commercialize ris-rez outside of mainland China, Taiwan, Hong Kong and Macau. Up to $1.525 billion is on the line in milestones.
