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

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.

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

Yong Jae Lee, MD, PhD

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Dr Lee on Responses With Nivolumab in Resectable dMMR Endometrial Cancer