The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Neoadjuvant nivolumab plus relatlimab produced high rates of pathologic complete response (pCR) and major pathologic response (MPR) in patients with resectable stage III-IV melanoma, according to a presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

The results, from a phase 2 trial ( Identifier: NCT02519322), were presented by Rodabe Navroze Amaria, MD, of The University of Texas MD Anderson Cancer Center in Houston.

Dr Amaria and colleagues conducted the trial to determine if neoadjuvant therapy with nivolumab and relatlimab would safely produce a high pCR rate in melanoma patients.

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The trial included 30 patients with surgically resectable clinical stage III or oligometastatic stage IV melanoma. The patients’ median age was 60 years, 19 were men, and most (60%) had stage IIIB or IIIC (26%) disease.

Patients received intravenous nivolumab (480 mg) and relatlimab (160 mg) on weeks 1 and 5. They had repeat imaging for response at week 9. Then, they proceeded to surgery, with surgical assessment of pathologic response.

After surgery, patients received up to 10 additional doses of nivolumab and relatlimab. Scans to detect recurrence were performed every 3 months.

Among the 29 evaluable patients, the overall radiographic response rate was 57%. The pCR rate was 59%, and the near pCR rate was 7%, which translates to an MPR rate of 66%. The partial pathologic response rate was 7%.

The median follow-up was 16.2 months. The 1-year relapse-free survival rate was 93%, and the 1-year overall survival rate was 95%.

The 1-year relapse-free survival rate was 100% for patients who achieved an MPR and 80% for patients without an MPR (P =.016).

During neoadjuvant therapy, there were no grade 3/4 treatment-related adverse events (TRAEs). During adjuvant treatment, the rate of grade 3 TRAEs was 26%, and there were no grade 4 TRAEs.

Adrenal insufficiency (13%), transaminitis (8%), and hyponatremia (8%) were the most common grade 3 TRAEs.

“Neoadjuvant nivolumab and relatlimab achieved high rates of both pathologic complete response and major pathologic response,” Dr Amaria concluded. “Compared to other neoadjuvant regimens, I believe that this regimen produces similar efficacy but definitely reduced toxicity in the neoadjuvant setting.”

Disclosures: This research was supported by Bristol Myers Squibb and the MD Anderson Melanoma Moonshot Program. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Read more of Cancer Therapy Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.


Amaria RN, Postow MA, Tetzlaff MT, et al. Neoadjuvant and adjuvant nivolumab (nivo) with anti-LAG3 antibody relatlimab (rela) for patients (pts) with resectable clinical stage III melanoma. J Clin Oncol. 2021;39:(suppl 15; abstr 9502). doi:10.1200/JCO.2021.39.15_suppl.9502