Yong Jae Lee, MD, PhD, is from the Yonsei University College of Medicine

 Dr Lee on the Preliminary Safety of Nivolumab for Resectable dMMR Endometrial Cancer

"The most common adverse effects was dermatitis or skin rash, which [was in line with] other immune-oncology trials. Just 2 patients [experienced] grade 3 adverse effects: 1 patient [had] anemia, and 1 patient had skin rash."

Yong Jae Lee, MD, PhD, an associate professor at Yonsei University College of Medicine, discussed the clinical relevance of preliminary safety findings from the phase 2 NIVEC trial (NCT05795244), which evaluated nivolumab (Opdivo) in patients with completely resectable mismatch repair–deficient (dMMR) endometrial cancer.

Findings from the trial presented at the 

2025 SGO Annual Meeting on Women’s Cancer

 demonstrated a clinical complete response (CR) rate of 80% in patients treated with nivolumab (n = 15), suggesting its potential utility as an alternative to surgery for patients who are unable or unwilling to undergo operative management. Among 12 patients to achieve a CR, 7 did not proceed to surgery and remained in follow-up at data cutoff. Notably, all 3 patients who did not experienced a CR had a partial response, including 2 patients with stage IA disease and 1 patient with stage IB disease.

Lee emphasized the favorable safety profile observed in the trial. Adverse effects (AEs) did not lead to treatment discontinuation in any patients. The most common AEs were dermatologic, such as skin rash or dermatitis (any-grade, 30%), and were consistent with other trials of immune checkpoint inhibitors. Two patients experienced grade 3 AEs events—one case of anemia and one case of skin rash. The latter was well controlled using topical corticosteroids or systemic steroid therapy, Lee said. No unexpected immune-related toxicities or treatment-limiting AEs were reported.

Based on these preliminary findings, Lee stated that immune checkpoint inhibition with nivolumab may offer a viable non-surgical therapeutic alternative in patients with resectable dMMR cervical cancer. He underscored the importance of further evaluation to confirm the long-term benefit of this approach, particularly in patients for whom standard surgical intervention is not feasible.

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Yong Jae Lee, MD, PhD, discusses the clinical relevance of the preliminary safety of nivolumab for resectable mismatch repair–deficient endometrial cancer.

Dr Lee on Responses With Nivolumab in Resectable dMMR Endometrial Cancer

“In the 15 patients, we completed the 6 cycles of nivolumab. Twelve patients, which is 80.0% of patients, achieved a cCR.”

Yong Jae Lee, MD, PhD, of the Yonsei University College of Medicine, discusses findings from the single-arm, phase 2 trial NIVEC trial (NCT05795244) investigating the PD-1 inhibitor nivolumab (Opdivo) in patients with completely surgically resectable mismatch repair–deficient (dMMR) endometrial cancer.

This multicenter, prospective study enrolled patients with stage I to III surgically resectable dMMR or microsatellite instability–high endometrial cancer, including carcinosarcoma, who had an ECOG performance status of 1 or 0 and had not received prior immune checkpoint inhibition. Patients received intravenous nivolumab at 480 mg every 4 weeks for 6 cycles. Following imaging and biopsy, patients with residual disease underwent surgery and subsequently received adjuvant treatment, whereas patients who achieved a clinical complete response (CR) with nivolumab underwent nonoperative follow-up every 3 months. The primary end point was the rate of pathologic CR or clinical CR (cCR). Secondary end points included objective response rate, progression-free survival, overall survival, and safety.

Among 15 evaluable patients, the cCR rate was 80.0%; these patients displayed no evidence of tumor on imaging or biopsy. The remaining 3 patient had partial responses (PR). Seven of the 12 responders did not undergo surgery. Radiological best responses included CR (n = 7), PR (n = 2), not available (n = 1), and not evaluable (n = 5).

The most common any-grade adverse effects (AEs) observed in the trial included skin rash/dermatitis (30%); hypothyroidism/thyroiditis (15%); increased alanine aminotransferase/aspartate aminotransferase levels (15%); increased thyroid-stimulating hormone (TSH) levels (6%); and decreased TSH, anemia, anorexia, depression, limb edema, fatigue, gingival pain, infusion-related reaction, eyelid edema, mucositis ulcer, and vaginitis (3% each). Grade 3/4 skin rash/dermatitis and anemia occurred in 1 patient each. No AEs led to treatment discontinuation.

Lee reported lecture-related personal financial interests with AstraZeneca, MSD, and Takeda; as well as institutional financial interests with Corcept Therapeutics and ONO.

Yong Jae Lee, MD, PhD, discusses key efficacy outcomes with nivolumab monotherapy in completely surgically resectable dMMR endometrial cancer.

Yong Jae Lee, MD, PhD

Articles

Dr Lee on the Preliminary Safety of Nivolumab for Resectable dMMR Endometrial Cancer

Dr Lee on Responses With Nivolumab in Resectable dMMR Endometrial Cancer