New Cancer Vaccine Shows Promise in Melanoma

A new cancer vaccine targeting melanoma, currently the subject of a phase 2 trial, has shown “promising” results, as one researcher tells CURE®.

Patients with stages 3 and 4 melanoma are enrolling in the trial, spearheaded by lead investigator Dr. James Smithy of Memorial Sloan Kettering Cancer Center in New York City, to receive the combination peptide vaccine IO102/IO103 plus the immunotherapy Opdualag, a combination of Opdivo (nivolumab) and relatlimab-rmbw.

Smithy told CURE® in an interview that approximately 21 patients had been recruited to date, with researchers hoping to reach a full cohort of 43 participants soon. A prior trial in Europe resulted in an 80% objective response rate (patients whose disease responded partially or completely to treatment), according to a news release, and Smithy said researchers planned to release the first data from the American trial, MSK-098, in mid-2025.

More on this topic: Cancer Vaccines Are a ‘Marvel’

Opdualag was approved by the Food and Drug Administration in 2022 for the treatment of patients 12 years and older with unresectable (cannot be removed by surgery) or metastatic (spread from its original site to other parts of the body) melanoma. Side effects have previously been reported to include itchiness, fatigue, rash, joint stiffness, diarrhea and vitiligo, or the loss of skin color in certain areas.

“We know that frontline, or first treatment, with immunotherapy, works at best, very well in only about half of melanoma patients,” Smithy said. “There's always an opportunity to have more effective treatments that work for a broader percentage of patients.

“And then, the other big thing is these therapies that we [currently] have combination immunotherapy can have pretty significant toxicity as well with immune-related side effects. So, we're looking for novel approaches or new ways to have higher rates of response with lower rates of severe immune-related side effects. So, we're hoping that the addition of this vaccine to [Opdualag] does add some additional benefit in terms of more responses without adding a lot of additional toxicity. And so far, I think it's been promising.”

Among the sites hosting the trial is Lehigh Valley Topper Cancer Institute in Allentown, Pennsylvania, via a partnership between that institution and Memorial Sloan Kettering Cancer Center that Smithy described as a “very exciting collaboration.”

“For us, I think it's a way to bring academic trials and research ideas to a broader set of centers, and especially in these academic community centers, beyond New York City,” Smithy said. “And so, for us, it helps speed up enrollment and get answers about these drugs more quickly, and then provides access to these kinds of new innovative therapies to people beyond our immediate reach here in Manhattan.”

‘The Biggest Thing Happening Now’

Dr. Suresh Nair, Lehigh Valley Topper Cancer Institute physician-in-chief and chair of the Medical Oncology Board of the American Board of Internal Medicine, is the lead researcher for the trial at Lehigh Valley.

The trial, Nair explained, is “patient-friendly,” “because essentially, they're getting standard of care plus a vaccine. This particular trial is a phase 2, non-randomized trial, so everybody is getting the vaccine, which from a patient standpoint is a plus. Because we're trying to replicate the 80% response rate seen in very limited testing in Norway.”

Nair explained how the vaccine works to treat melanoma, and what it could represent in the armamentarium of cancer treatment.

“From a patient perspective, there's been a lot of progress in the treatment of stage 4, or metastatic melanoma in the last decade. … The main advances have been medicines that take the brakes off our T cells,” Nair said. “These breaks put our T cells to sleep. But there are still other brakes that we have to overcome. Personalized vaccines are the biggest thing happening now in cancer, I would say for this year and next year.

“These personalized vaccines will work with the current immunotherapy medicines to really let the patient's T cells find the cancer and potentially double the effectiveness. The same sea change we saw a decade ago may happen in the next couple of years. … We're actually vaccinating and decreasing the effect of the bad T cells that are making our body think that cancer belongs to the body and helping the helper T cells whose job is to eradicate the cancer.”

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