NextCure Presents Phase 1b Data on NC410 and Pembrolizumab Combination at ASCO 2024
- Of the evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 2 confirmed ongoing PRs and a disease control rate of 51%
- Of the 7 evaluable ovarian cancer patients, there were 3 PRs and a disease control rate of 43%
- Data to be presented
June 1, 2024 ,9:00 am-12:00 pm CT
The poster presentation highlights the safety and tolerability of doses between 30-200 mg of NC410 in combination with 400 mg of pembrolizumab. The combination resulted in partial responses (PR) and stable disease in both CRC and ovarian cancer. Most adverse events were limited to Grades 1 and 2.
“While MSS/MSI-L CRC and ovarian cancer are difficult to treat and recalcitrant to immunotherapy, the combination of NC410 and pembrolizumab demonstrated clinical activity against both tumor types. MSS/MSI-L CRC study subjects who achieved clinical benefit of partial responses or stable disease by the first scan at 9 weeks maintained continued disease control with a median duration of 5.5 months, which is clinically meaningful for this patient population,” said Michael Richman NextCure’s President and chief executive officer. “In addition, biomarker data support the proposed mechanism of action of NC410 in remodeling the ECM, enhancing infiltration and activation of immune cells in the TME. While the focus of the current presentation is on the targeted CRC patient population, we look forward to reporting the results from the ongoing ovarian cancer cohort expansion later this year.”
Key findings:
- Of the 37 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis treated with 100 mg of NC410, there were 2 confirmed ongoing PRs (12.5 months and 7.4 months) and 17 with stable disease. For this cohort, the median duration of disease control was 5.5 months, the disease control rate (DCR) was 51.3% [CI: 34.4, 68.1] and the overall response rate (ORR) was 5.4% [CI: 0.7, 18.2].
- Of the 7 evaluable ovarian cancer patients in the 100 mg and 200 mg cohorts, there were 3 PRs {1 continued for 7.9 months (200 mg), 1 for 4.1 months (100 mg), and 1 ongoing at 5.1 months (100 mg)}. For this cohort, the DCR was 43% and ORR was 43%.
- Diarrhea and fatigue were the most commonly reported adverse events (AEs). Amongst the 81 patients treated at all dose levels of NC410 in the Phase 1b portion of the trial, 39.5% had Grade ≥3 Treatment Emergent (TEAE) and 4.9% had Grade ≥3 Treatment-Related (TRAE); 1 participant discontinued study due to Grade 3 myocarditis.
Details of the presentation are as follows:
Title: A Phase 1b study of NC410 in combination with pembrolizumab in immune checkpoint inhibitor (ICI) naïve, and refractory microsatellite stable (MSS)/microsatellite instability-low (MSI-L) colorectal cancer (CRC) and ovarian cancer
Date and Time:
Session: Poster Session: Developmental Therapeutics—Immunotherapy
Abstract Number: 2538
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