Corvus Pharmaceuticals Announces Presentation of Additional Data from the Phase 1/1b Clinical Trial of Soquelitinib for Patients with T Cell Lymphoma

Rhea-AI Summary

Corvus Pharmaceuticals (NASDAQ: CRVS) has presented additional data from its Phase 1/1b clinical trial of soquelitinib for T cell lymphoma (TCL) treatment at the 16th Annual T-Cell Lymphoma Forum. The trial showed promising results with:

• 39% objective response rate (9 out of 23 evaluable patients)
• 26% complete response rate (6 patients)
• 17.2 months median duration of response
• 6.2 months median progression-free survival
• 30% progression-free survival rate at 18 months

The company is currently conducting a registrational Phase 3 trial enrolling 150 patients with relapsed Peripheral T cell lymphoma, comparing soquelitinib to belinostat or pralatrexate. Soquelitinib has received FDA Orphan Drug Designation for T cell lymphoma and Fast Track designation for relapsed/refractory PTCL treatment.

Positive

• Strong efficacy with 39% objective response rate and 26% complete response rate
• Superior 18-month progression-free survival rate (30%) compared to existing treatments (<20%)
• Long duration of response at 17.2 months median
• Well-tolerated safety profile with no new safety signals
• FDA Fast Track and Orphan Drug designations received

Negative

• Median progression-free survival to 6.2 months
• 61% of patients did not achieve objective response
• No FDA fully approved agents exist for relapsed PTCL, indicating challenging regulatory pathway

Insights

Financial Analyst

Corvus Pharmaceuticals has released encouraging Phase 1/1b data for soquelitinib in T-cell lymphoma that significantly strengthens its clinical profile and commercial potential. The 39% objective response rate with 26% complete responses represents a potentially differentiated efficacy profile compared to current standards of care like belinostat and pralatrexate.

The 17.2-month median duration of response and 6.2-month median progression-free survival with 30% PFS rate at 18 months indicate substantial durability advantages over existing options, which typically show 18-month PFS rates below 20%. This suggests soquelitinib could potentially establish a new efficacy benchmark in a market with effective options.

Corvus is leveraging these promising results with an ongoing registrational Phase 3 trial comparing soquelitinib against physicians' choice of belinostat or pralatrexate. The FDA's granting of both Orphan Drug and Fast Track designations provides regulatory advantages that could accelerate approval timelines.

The absence of safety signals requiring dose reductions or interruptions is particularly notable, as better tolerability could drive stronger real-world adoption compared to existing therapies with challenging side effect profiles. The company is also diversifying soquelitinib's potential with a Phase 1 trial in atopic dermatitis expected to deliver data in Q2 2025, potentially expanding its market opportunity beyond oncology.

Data to be presented in oral session and poster at the 16th Annual T-Cell Lymphoma Forum

SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that additional data from the Company’s Phase 1/1b clinical trial of soquelitinib for the treatment of patients with T cell lymphoma (TCL) is being presented at the 16^th Annual T-Cell Lymphoma Forum taking place March 20-22, 2025 in San Diego, CA.

“The data from the Phase 1/1b clinical trial of soquelitinib in patients with T cell lymphoma continues to demonstrate strong indications of anti-tumor activity in a significant number of patients,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “We are encouraged by the high complete response, prolonged median progression free survival and high rate of 18-month progression free survival, which all appear superior to standard of care agents such as belinostat and pralatrexate. In addition, analysis of patient blood samples at baseline and on treatment show that soquelitinib reduces T cell exhaustion, which may allow for improved T cell function and anti-tumor immunity. Supported by this data, our registrational Phase 3 trial of soquelitinib is enrolling patients with relapsed peripheral T cell lymphoma at multiple sites in the U.S., Canada and Australia, along with our Phase 1 trial in atopic dermatitis that is anticipated to deliver data in the second quarter 2025.”

The soquelitinib data from the Phase 1/1b clinical trial of soquelitinib for TCL will be presented by John Reneau, MD, PhD, Assistant Professor in the College of Medicine and The Ohio State University Comprehensive Cancer Center. Dr. Reneau is a hematologist who specializes in treating patients with lymphoma and an investigator in the trial. The details of Dr. Reneau’s presentations are as follows:

Oral Presentation

• Title: Selective ITK Inhibition for Treatment of PTCL
• Time: 4:50 – 5:10 pm PT on March 20, 2025

Poster Presentation

• Abstract Title: Soquelitinib, a Selective ITK Inhibitor for Treatment of T Cell Lymphomas: Results of Ph1 trial Reveal Novel Mechanisms of Action
  

Soquelitinib Phase 1/1b Overview and Key Data
A total of 25 patients were enrolled in the Phase 1/1b trial at the optimum 200 mg two-times a day dose and would have met the eligibility criteria for the ongoing registrational Phase 3 clinical trial based on ≥1 and ≤3 prior therapies, including 23 evaluable patients. For the 23 evaluable patients:

• Objective responses (complete response, CR, plus partial response, PR) were seen in nine patients (39%), including six CRs (26%) and three PRs.
• The median duration of response (DOR) for the nine patients with objective response by Lugano criteria was 17.2 months.
• Three patients continue on therapy at 25+ months, 18+ months and 14+ months.
• Kaplan Meier estimated median progression free survival (PFS) was 6.2 months.
• At 18-month follow-up, the PFS rate was 30%, which compares favorably to 18-month PFS of <20% with belinostat or pralatrexate.^{1 2}
• Peripheral blood samples were collected from patients both prior to the initiation of soquelitinib therapy and during the course of treatment. These samples were analyzed for markers of T cell exhaustion in normal T cells. The results indicated that the majority of patients exhibited a reduction in T cell exhaustion markers on both CD4+ and CD8+ cells after 21 days of treatment. T cell exhaustion is a state in which T cells exhibit diminished functionality due to prolonged exposure to antigens.
• Soquelitinib was well-tolerated, with no new safety signals, drug interruptions or dose reductions.
  

Based on the results from the Phase 1/1b trial, Corvus is enrolling patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed Peripheral T cell lymphoma (PTCL) at multiple sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is PFS. There are no FDA fully approved agents for the treatment of relapsed PTCL and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy.

About Peripheral T Cell Lymphoma
Peripheral T cell lymphoma (PTCL) is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in western populations, reaching 20% to 25% of NHL in some parts of Asia and South America. The most common subtypes are PTCL-not otherwise specified (PTCL-NOS) and T follicular helper cell lymphoma. Initial therapy for these diseases is typically combination chemotherapy; however, approximately 75% of patients either do not respond or relapse within the first two years. Patients in relapse are treated with various chemotherapy agents but have poor overall outcomes with median progression-free survival in the 3 to 4 month range and overall median survival of 6 to 12 months. There are no approved drugs in relapsed PTCL based on randomized trials.
PTCL is a disease of mature helper T cells that express ITK (interleukin-2-inducible T cell kinase), often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.

About Soquelitinib
Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation which has the potential to suppress autoimmune and inflammatory reactions. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the Company is conducting a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also being investigated in a randomized placebo-controlled Phase 1 clinical trial in patients with atopic dermatitis and a Phase 2 clinical trial in patients with autoimmune lymphoproliferative syndrome (ALPS), a rare genetic disease. A recent publication describing the chemistry, enzymology and biology of soquelitinib appeared in NPJ Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancers and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.

Forward-Looking Statements
This press release contains forward-looking statements related to the potential of the Company’s product candidates including soquelitinib. This includes the outlook for the registrational Phase 3 trial of soquelitinib; the potential use of soquelitinib to treat autoimmune lymphoproliferative syndrome and other immune diseases; the Company’s conduct of, enrollment in and timing of clinical trials and results; and the potential of ITK inhibition as a new approach to immunotherapy. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2024, filed with the Securities and Exchange Commission on November 12, 2024, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient number of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:
Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

MEDIA CONTACT:
Sheryl Seapy
Real Chemistry
+1-949-903-4750
sseapy@realchemistry.com

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¹ O’Connor O. et. al. J. Clin Onc 33:2492, 2015
² O’Connor O. et. al. J. Clin Onc 29:1182, 2011

FAQ

What are the key efficacy results from CRVS's soquelitinib Phase 1/1b trial in T cell lymphoma?

The trial showed 39% objective response rate, 26% complete response rate, 17.2 months median duration of response, and 30% progression-free survival at 18 months.

How many patients are expected to enroll in CRVS's Phase 3 soquelitinib trial?

The registrational Phase 3 trial is anticipated to enroll 150 patients with relapsed Peripheral T cell lymphoma.

What regulatory designations has soquelitinib received from the FDA?

Soquelitinib has received FDA Orphan Drug Designation for T cell lymphoma and Fast Track designation for relapsed/refractory PTCL.

How does soquelitinib's 18-month progression-free survival rate compare to existing treatments?

Soquelitinib showed 30% progression-free survival at 18 months, compared to less than 20% with belinostat or pralatrexate.

What is the primary endpoint of CRVS's Phase 3 soquelitinib trial?

The primary endpoint of the Phase 3 trial is progression-free survival (PFS).