Moderna shares soar on melanoma drug trial success

Investing.com -- Moderna Inc shares jumped as much as 50% in pre-market trading Wednesday after the company and Merck announced their melanoma drug combination outperformed Keytruda alone in a Phase 3 trial.

The INTerpath-001 trial tested intismeran autogene, an investigational mRNA-based individualized neoantigen therapy, combined with Merck's Keytruda in patients with completely resected stage IIB-IV melanoma. The trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival.

The combination showed statistically significant improvements in both measures compared to Keytruda alone for patients with completely resected stage IIB, IIC, III or IV cutaneous melanoma who had not received prior systemic therapy treatment.

This marks the first positive Phase 3 readout for an individualized neoantigen therapy and for an mRNA-based cancer therapy. The trial also represents the first Phase 3 study to show clinically meaningful improvement over Keytruda alone in the adjuvant setting for patients with resected melanoma.

The safety profiles of intismeran and Keytruda remained consistent with previously reported studies, with no new safety signals observed. The study will continue to evaluate other key secondary endpoints, including overall survival.

The companies plan to present the data at an upcoming international medical meeting and share the results with regulatory authorities.

Merck and Moderna are currently running nine Phase 2 and Phase 3 clinical trials across multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.

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