NextCure Presents Phase 1b Data on NC410 and Pembrolizumab Combination at ASCO 2024

Rhea-AI Summary

NextCure (Nasdaq: NXTC) announced promising results from its Phase 1b study of NC410 in combination with pembrolizumab, presented at ASCO 2024. The study focused on patients with MSS/MSI-L colorectal cancer (CRC) and ovarian cancer. Key findings include a 51% disease control rate in CRC patients and a 43% rate in ovarian cancer patients. Two CRC patients had ongoing partial responses (PR) and a median disease control duration of 5.5 months. In ovarian cancer, three patients experienced PRs with a 43% overall response rate. Adverse events were mostly mild, but 39.5% of patients had Grade ≥3 Treatment Emergent Adverse Events (TEAE), and 4.9% had Grade ≥3 Treatment-Related Adverse Events (TRAE). A poster presentation by Dr. Eric S. Christenson will detail these findings on June 1, 2024, at the ASCO Annual Meeting in Chicago.

Positive

• NC410 and pembrolizumab combination showed 51% disease control rate in MSS/MSI-L CRC patients.
• In ovarian cancer cohort, the combination achieved a 43% disease control rate.
• Two CRC patients had ongoing partial responses, maintaining disease control for up to 12.5 months.
• Median duration of disease control in CRC was 5.5 months, which is clinically meaningful.
• Three ovarian cancer patients had partial responses with a 43% overall response rate.
• Adverse events were mostly mild (Grades 1 and 2), indicating good tolerability.

Negative

• 39.5% of patients experienced Grade ≥3 Treatment Emergent Adverse Events (TEAE).
• 4.9% of patients faced Grade ≥3 Treatment-Related Adverse Events (TRAE).
• One participant discontinued the study due to Grade 3 myocarditis.
• The overall response rate for MSS/MSI-L CRC patients was relatively low at 5.4%.

Oncology Doctor

The clinical data from NextCure's Phase 1b study on NC410 combined with pembrolizumab is quite promising for patients with MSS/MSI-L CRC and ovarian cancer. Typically, these cancers are difficult to treat, especially with immunotherapy. Demonstrating partial responses (PRs) and achieving a disease control rate (DCR) of 51.3% in MSS/MSI-L CRC patients is encouraging. The median duration of disease control of 5.5 months is clinically significant as it offers a tangible benefit to patients with limited treatment options. For ovarian cancer, the DCR of 43% and ORR of 43% further validate the combination's potential efficacy. The most frequently observed adverse events, diarrhea and fatigue, being largely limited to Grades 1 and 2, suggest a manageable safety profile. Therefore, this data could represent a meaningful advance in the treatment landscape for these cancers.

Financial Analyst

From a financial perspective, the positive preliminary results from NextCure's Phase 1b trial could potentially enhance investor confidence and have a favorable impact on the stock. The demonstration of clinical activity in hard-to-treat cancers like MSS/MSI-L CRC and ovarian cancer is significant. However, it is important to note that these are early-stage results. Investors should consider that while the data is promising, it will require further validation through larger Phase 2 and Phase 3 trials. The data showing a 51.3% DCR in CRC and a 43% DCR in ovarian cancer is impressive, especially considering the challenging nature of these cancers. However, the transition from Phase 1b to later stages can often be fraught with challenges and uncertainties. As such, while the news is positive, the long-term financial implications will become clearer as the compound progresses through the clinical pipeline.

Market Research Analyst

The market landscape for oncology treatments is highly competitive, with numerous companies vying for attention. The data presented by NextCure offers them a unique position given the targeted patient population of MSS/MSI-L CRC and ovarian cancer. These patient groups often have limited options and a new therapy showing efficacy could capture a substantial portion of the market. The focus on tumor types that are refractory to immunotherapy positions NC410 in a niche but potentially lucrative segment. The combination with pembrolizumab, a well-established immunotherapy, could also offer synergistic benefits and enhance the marketability of NC410. The relatively high rates of disease control and partial responses in these early stages suggests a strong foundation upon which the company can build its commercialization strategy in the future.

• 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
  

BELTSVILLE, Md., May 30, 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 will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The trial evaluated the combination in immune checkpoint inhibitor (ICI) naïve and refractory microsatellite stable (MSS)/microsatellite instability-low (MSI-L) colorectal cancer (CRC) and ovarian cancer and demonstrated clinical activity in these hard-to-treat cancers. The data will be presented in a poster session by clinical trial investigator Eric S. Christenson, M.D., Assistant Professor of Oncology at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.

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: June 1, 2024, 9:00 am-12:00 pm CT
Session: Poster Session: Developmental Therapeutics—Immunotherapy
Abstract Number: 2538

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. Examples of forward-looking statements in this press release include, among others, statements about NextCure’s plans, objectives, and intentions with respect to the discovery of immunomedicine targets and the discovery and development of immunomedicines. 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 the unproven approach to the discovery and development of product candidates based on our FIND-IO platform. 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 are the key results of NextCure's Phase 1b study presented at ASCO 2024?

The study showed a 51% disease control rate in MSS/MSI-L CRC patients and a 43% disease control rate in ovarian cancer patients.

What was the disease control rate for MSS/MSI-L CRC patients treated with NC410 and pembrolizumab?

The disease control rate was 51%.

How did ovarian cancer patients respond to the NC410 and pembrolizumab combination?

The combination achieved a 43% disease control rate and a 43% overall response rate in ovarian cancer patients.

What were the adverse events reported in the NC410 and pembrolizumab study?

Common adverse events were diarrhea and fatigue, with 39.5% experiencing Grade ≥3 TEAEs and 4.9% experiencing Grade ≥3 TRAEs.

How long did CRC patients maintain disease control with NC410 and pembrolizumab?

CRC patients maintained disease control for a median of 5.5 months.

What is the significance of the partial responses in the NC410 study?

Partial responses were significant, with some CRC patients maintaining disease control for up to 12.5 months, indicating promising clinical activity.