MRNA & MRK's Personalized Cancer Therapy Delivers Strong 5-Year Data

Shares of Moderna MRNA were up 15.8% on Jan. 21, after the company and its partner Merck MRK announced positive median five-year follow-up data from a phase IIb study, which evaluated their personalized cancer therapy combo in certain patients with high-risk melanoma, a serious form of skin cancer.

The KEYNOTE-942/mRNA-4157-P201 study evaluated Moderna’s investigational mRNA-based individualized neoantigen therapy (INT), intismeran autogene (mRNA-4157 or V940), in combination with Merck’s blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), for treating patients with high-risk melanoma (stage III/IV) following complete resection.

Data from this pre-planned follow-up analysis showed that adjuvant treatment with intismeran autogene + Keytruda continued to demonstrate sustained and clinically meaningful improvement in recurrence-free survival — the primary endpoint of the study. The combo therapy reduced the risk of recurrence or death by 49% versus Keytruda alone in patients with high-risk melanoma following complete resection.

Per the company, patients suffering from stage III/IV melanoma remain at high risk of recurrence following surgery. The study demonstrating the long-term potential of intismeran autogene combined with Keytruda to lower the risk of recurrence in certain patients with melanoma marks an important milestone.

Moderna and Merck plan to share additional follow-up data on primary and secondary endpoints at an upcoming medical meeting.

This analysis from the phase IIb KEYNOTE-942/mRNA-4157-P201 study builds on the primary analysis conducted at around two years of follow-up and a subsequent analysis at three years of follow-up. The safety profile of intismeran autogene in combination with Keytruda in the study remains similar to that seen in previously reported studies.

MRNA’s Stock Price Performance

MRNA stock hit a 52-week high following the announcement of the above news. In the past six months, shares of Moderna have rallied 60.8% compared with the industry’s rise of 21.5%.

MRNA’s Ongoing Development Activities With Intismeran Autogene

Intismeran autogene is an experimental, personalized mRNA-based cancer therapy that is designed using the unique genetic mutations found in a patient’s tumor and can target up to 34 tumor-specific antigens.

Besides the melanoma indication, Moderna and Merck are evaluating the therapy in two pivotal phase III studies in the non-small cell lung cancer (NSCLC) space. Moderna and Merck are also evaluating the therapy across various mid-to-late-stage studies for other cancer indications, including melanoma, bladder cancer and renal cell carcinoma. A commercial launch for this cancer therapy is targeted for next year.

Based on the success achieved with intismeran autogene, Moderna is now focusing on expanding its oncology pipeline. It is also prioritizing the development of mRNA-4359, an investigational checkpoint adaptive immune modulation therapy, currently being evaluated in early-to-mid-stage studies for first-line melanoma and first-line metastatic NSCLC. A data readout on the phase II portion of this study is expected later in 2026.

Moderna, Inc. Price

Moderna, Inc. price | Moderna, Inc. Quote

MRNA’s Zacks Rank & Stocks to Consider

Moderna currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Alkermes ALKS and Immunocore IMCR, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Alkermes’ 2026 earnings per share (EPS) have increased from $1.54 to $1.90. Shares of ALKS have gained 27% over the past six months.

Alkermes’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 4.58%.

Over the past 60 days, Immunocore’s loss per share estimates for 2026 have decreased from 97 cents to 90 cents. Shares of IMCR have lost 4.6% over the past six months.

Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 53.96%.

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