Moderna looks to a subcutaneous Keytruda combo

Moderna, awaiting key phase 3 data with its Merck & Co-partnered neoantigen immunotherapy intismeran autogene in adjuvant melanoma, is continuing to branch out. A new study, Interpath-014, will test the project alongside subcutaneous Keytruda Qlex in adjuvant NSCLC, according to a new clinicaltrials.gov listing. The study adds to two ongoing adjuvant NSCLC phase 3s: Interpath-002, in patients without prior neoadjuvant therapy; and Interpath-009, in those who didn’t completely respond to neoadjuvant Keytruda plus chemo. Unlike Interpath-014, both use IV Keytruda. In addition, Interpath-002 and 009 are recruiting stage II-IIIB patients, while Interpath-014 will enrol those with earlier stage I disease. This might help explain why the new study will compare inti-gene, with or without Keytruda, versus placebo; Interpath-002 and 009 are testing an inti-gene/Keytruda combo versus Keytruda alone. Interpath-014 is set to start in May. A big readout for inti-gene is looming, from the Interpath-001 trial in adjuvant melanoma. Data are expected in 2026, and Moderna’s stock has climbed in anticipation of a positive result. However, Moderna seemed to raise doubts about the timing of the readout in its fourth-quarter press release, saying it expects the Interpath-001 results “potentially in 2026”.

Phase 3 trials of Moderna/Merck & Co’s intismeran autogene

Note: *phase 2/3. Source: OncologyPipeline & clinicaltrials.gov.