Investing.com -- Shares of Moderna Inc. $MRNA (+3,98%) saw their price jump by as much as 50% in premarket trading on Wednesday. This followed an announcement by the company and its partner Merck that a combination melanoma therapy outperformed Keytruda monotherapy in a Phase 3 trial.
The INTerpath-001 trial evaluated Intismeran Autogen, an investigational, mRNA-based personalized neoantigen therapy, in combination with Merck’s Keytruda in patients with completely resected Stage IIB–IV melanoma. The study met its primary endpoint of recurrence-free survival as well as a key secondary endpoint, distant metastasis-free survival.
The combination demonstrated statistically significant improvements in both measures compared to Keytruda alone in patients with completely resected cutaneous melanoma in stages IIB, IIC, III, or IV who had not previously received systemic therapy.
This is the first positive Phase 3 study result for an individualized neoantigen therapy and for an mRNA-based cancer therapy. The study is also the first Phase 3 trial to demonstrate a clinically meaningful improvement over Keytruda monotherapy in adjuvant therapy for patients with resected melanoma.
The safety profiles of intismeran and Keytruda were consistent with those from previous studies; no new safety signals were 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 conference and submit the results to regulatory authorities.
Merck and Moderna are currently conducting nine Phase 2 and 3 clinical trials for various tumor types, including melanoma, non-small cell lung cancer, bladder cancer, and renal cell carcinoma.
