Scholar Rock, a biopharmaceutical company focusing on innovative treatments for conditions like spinal muscular atrophy (SMA) and cardiometabolic disorders, is set to present new safety and efficacy results from its Phase 1 DRAGON proof-of-concept trial. The trial involves SRK-181 in combination with pembrolizumab for patients with advanced solid tumors. These findings will be shared during the American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago. A deeper discussion will follow on June 4th via webcast, featuring Scholar Rock's Chief Medical Officer, Jing Marantz, M.D., Ph.D., and Dr. Toni Choueiri, M.D., from the Dana-Farber Cancer Institute.
Jay Backstrom, M.D., M.P.H., President and CEO of Scholar Rock, highlighted the potential of SRK-181, noting its effectiveness in previously treated patients across various cancer types. Backstrom emphasized that biomarker data revealed an enhanced proinflammatory microenvironment and increased anti-tumor activity when using SRK-181.
Key data from the study include:
- SRK-181 demonstrated good tolerability during the dose expansion phase.
- Positive responses were observed in multiple cancer types, including clear cell renal cell carcinoma, head and neck squamous cell carcinoma, melanoma, and urothelial carcinoma.
- Biomarker data indicated that SRK-181 combined with pembrolizumab fostered a proinflammatory environment in patients resistant to anti-PD-(L)1 therapy.
- Patients with clear cell renal cell carcinoma who had tumors initially infiltrated by CD8+ T cells and/or regulatory T cells showed higher response rates, suggesting a possible patient selection strategy.
This study will be presented at the ASCO Annual Meeting, in a session titled "Phase 1 study (DRAGON) of SRK-181 (linavonkibart), a latent TGFβ1 inhibitor, combined with pembrolizumab in anti-PD1 resistant patients with advanced solid tumors." It will be part of the Developmental Therapeutics—Immunotherapy Oral Session, presented by Ulka N. Vaishampayan, MD, from the University of Michigan, on June 3rd.
On June 4th, Scholar Rock will host a conference call to discuss the new data, featuring key members of their executive team and Dr. Choueiri. More information about these presentations and abstracts can be found on ASCO’s website, and the presentation will be available on Scholar Rock’s website following the conference.
SRK-181 is an investigational drug targeting TGFβ1, which plays a significant role in many tumors' resistance to immune checkpoint inhibitors. Scholar Rock believes that SRK-181 can potentially overcome this resistance, allowing for better anti-tumor responses when combined with anti-PD-(L)1 therapies. The DRAGON Phase 1 trial, which completed enrollment in December 2023, included patients with various cancers such as urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and clear cell renal cell carcinoma. While promising, SRK-181’s efficacy and safety are still under investigation, as it has not yet received FDA approval.
Scholar Rock, with a focus on transforming growth factor beta (TGFβ) biology, is dedicated to developing therapies for diseases with significant unmet needs. They have pioneered a muscle-targeted treatment for SMA and continue to explore innovative therapeutic approaches through their proprietary platform.
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