NextCure Presented Results of the Phase 1b Study of NC410 in Combination with Pembrolizumab at ESMO 2024
Rhea-AI Summary
NextCure (Nasdaq: NXTC) presented clinical data from the Phase 1b portion of a Phase 1b/2 study evaluating NC410, a LAIR-2 fusion protein, in combination with pembrolizumab at ESMO 2024. The trial demonstrated clinical activity in hard-to-treat cancers, including ovarian cancer and immune checkpoint inhibitor (ICI) naïve microsatellite stable (MSS)/microsatellite instability-low (MSI-L) colorectal cancer (CRC).
Key results include:
- 5 partial responses (PRs) out of 20 evaluable ovarian cancer patients
- 3 PRs out of 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis
- Biomarker data supporting the proposed mechanism of action of NC410
The combination showed durable responses in both tumor types, which are generally unresponsive to immunotherapy. NextCure plans to provide an update on patients remaining in the study later this year.
Positive
- Clinical activity demonstrated in hard-to-treat cancers (ovarian and MSS/MSI-L CRC)
- 5 partial responses out of 20 evaluable ovarian cancer patients
- 3 partial responses out of 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis
- Durable responses observed in both tumor types
- Biomarker data supports proposed mechanism of action of NC410
Negative
- None.
News Market Reaction
On the day this news was published, NXTC declined 5.00%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Of the 20 evaluable ovarian cancer patients, there were 5 PRs
- Of the 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 3 PRs
- Biomarker data support proposed mechanism of action of NC410
BELTSVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced that clinical data from the Phase 1b portion of a Phase 1b/2 study evaluating NC410, a LAIR-2 fusion protein, in combination with pembrolizumab was presented at ESMO 2024. The trial, which is evaluating the combination in ovarian cancer and immune checkpoint inhibitor (ICI) naïve and refractory microsatellite stable (MSS)/microsatellite instability-low (MSI-L) colorectal cancer (CRC), demonstrated clinical activity in these hard-to-treat cancers. The data were presented by clinical trial investigators Emese Zsiros, M.D., Ph.D., Associate Professor of Oncology, Chair, Department of Gynecologic Oncology, Roswell Park Comprehensive Cancer Center (ovarian) and Eric S. Christenson, M.D., Assistant Professor of Oncology at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (CRC). The presentations are available on the NextCure website (www.nextcure.com).
“The combination of NC410 and pembrolizumab continues to demonstrate clinical activity against ovarian cancer and MSS/MSI-L CRC, recalcitrant cancers that are generally unresponsive to immunotherapy. In both tumor types, study subjects who achieved clinical benefit of partial response or stable disease demonstrated durability of their responses that was clinically meaningful for these patient populations,” said Udayan Guha, M.D., Ph.D., NextCure’s Senior Vice President, Clinical and Translational Development. “We are continuing to follow the patients who remain on study and look forward to providing an update later this year.”
Presentation details:
Title: Results of the Phase 1b Study of NC410 Combined with Pembrolizumab in ovarian Cancer Patients
Lead Author: Emese Zsiros, M.D., Ph.D.
Presentation Number: 758P
Title: Results of the Phase 1b Study of NC410 Combined with Pembrolizumab in MSS/MSI-L Colorectal Cancer Patients
Lead Author: Eric S. Christenson, M.D.
Presentation Number: 577P
About NextCure, Inc.
NextCure is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or have disease progression on, current therapies, through the use of differentiated mechanisms of actions including antibody-drug conjugates, antibodies and proteins. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response. www.nextcure.com
Cautionary Statement Regarding Forward-Looking Statements
Statements made in this press release that are not historical facts are forward-looking statements. Words such as “expects,” “believes,” “intends,” “hope,” “forward” and similar expressions are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: our limited operating history and no products approved for commercial sale; our history of significant losses; our need to obtain additional financing; risks related to clinical development, including that early clinical data may not be confirmed by later clinical results; risks that pre-clinical research may not be confirmed in clinical trials; risks related to marketing approval and commercialization; and NextCure’s dependence on key personnel. More detailed information on these and additional factors that could affect NextCure’s actual results are described in NextCure’s filings with the Securities and Exchange Commission (the “SEC”), including NextCure’s most recent Form 10-K and subsequent Form 10-Q. You should not place undue reliance on any forward-looking statements. NextCure assumes no obligation to update any forward-looking statements, even if expectations change.
Investor Inquiries
Timothy Mayer, Ph.D.
NextCure, Inc.
Chief Operating Officer
(240) 762-6486
IR@nextcure.com
FAQ
What were the key results of NextCure's (NXTC) Phase 1b study of NC410 presented at ESMO 2024?
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When does NextCure (NXTC) plan to provide an update on the ongoing NC410 study?
What is NC410, the drug being studied by NextCure (NXTC)?
