Third pivotal trial for Moderna’s personalised immunotherapy
Moderna/Merck & Co’s personalised neoantigen immunotherapy mRNA-4157/V940 is shortly to enter its third pivotal study. The project, which Merck licensed in 2022 for $250 up front, will next month begin Interpath-007, a phase 2/3 trial testing it in perioperative cutaneous squamous cell carcinoma, new clinicaltrials.gov listings reveal. Like the first two pivotal studies, Interpath-001 in melanoma and 002 in lung cancer, 007 will see mRNA-4157 combined with Keytruda; however, unlike those first two tests, which focus on adjuvant treatment, the latest trial includes a neoadjuvant stage, followed by tumour resection, before a further adjuvant combo stage. If the decision to launch phase 3 trials in melanoma and NSCLC, based on just a handful of patients in Keynote-603, seemed quick, then the latest move is even more speculative: hints of activity in that phase 1 basket trial appear limited to responses in head and neck squamous cell carcinoma. Still, Interpath-007 has an adaptive design, with an initial 600 patients to be treated in a phase 2 phase that also includes Keytruda alone, before a decision is made whether to enrol an additional 412 and compare mRNA-4157 plus Keytruda versus standard of care alone.
Pivotal studies of mRNA-4157/V940
| Study | Setting | Design/primary endpoints |
|---|---|---|
| Interpath-001 | Adjuvant stage IIB or IIC, III, or IV cutaneous melanoma | Keytruda combo, vs Keytruda; recurrence-free survival |
| Interpath-002 | Adjuvant stage II, IIIA, IIIB (N2) NSCLC | Keytruda combo, vs Keytruda; disease-free survival |
| Interpath-007* | (Neo)adjuvant locally advanced stage II-IV (M0) cutaneous squamous cell carcinoma | Keytruda combo as neoadjuvant therapy, followed by Keytruda combo as adjuvant therapy, vs Keytruda + SoC (phase 2 stage only), or SoC alone; event-free survival |
Note: *phase 2/3. Source: OncologyPipeline.
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