FDA Grants Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma
Emerging data from Phase I first-in-human, dose-escalation study showed promising survival and progression-free survival rates.
The FDA has granted Fast Track Designation to Obsidian Therapeutics’ OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15), for the treatment of patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors (ICI).1
“FDA Fast Track Designation underscores the ongoing unmet need for patients with melanoma that has progressed on or after ICI therapy, agnostic of mutational status, and that OBX-115 may have the potential to address that unmet need,” Madan Jagasia, MD, chief executive officer of Obsidian said in a press release. “OBX-115 is poised to be a transformative treatment option due to its patient-centric focus, including compatibility with core needle biopsy tumor tissue procurement and positively differentiated safety and tolerability profile relative to non-engineered TIL cell therapy. We are highly encouraged by the most recent safety and efficacy data presented at the 2024 American Society of Clinical Oncology Meeting. With this designation, we look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in the broad post-ICI setting.”
Earlier in May, Obsidian announced positive clinical data for OBX-115 in patients with advanced melanoma. Emerging data from the Phase I first-in-human, single-center study (NCT05470283) showed that as of January 2, 2024, all 9 patients had disease that was primary-resistant to anti–PD-1 therapy, with a median of 3 (range, 1–6) lines of prior therapy. Post-infusion safety results included no dose limiting toxicities and no Grade 4 or higher non-hematologic treatment emergent adverse events (TAEs), and 2 patients with Grade 3 nonhematologic TEAEs.2
Additional safety and efficacy data was announced in June at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Among other additional findings from the Phase I study, Obsidian shared that emerging survival and progression-free survival (PFS) rates were promising, with no treatment- or disease-related mortality (OS 100%, median study follow-up of 29.5 weeks) and PFS of 75% at 24 weeks.3
In an earlier press release, Parameswaran Hari, MD, chief development officer of Obsidian commented: “We believe OBX-115 has the potential to advance the TIL cell therapy field in multiple ways, including enabling non-surgical tumor tissue procurement and abrogating the need for IL2. We are also exploring the ability to re-energize engrafted OBX-115 cells with acetazolamide re-dosing. We look forward to continuing to build on this momentum and apply key learnings from the first-in-human Phase I study to our ongoing Phase I/II multicenter study, where we are continuing to explore these attributes and optimize the OBX-115 regimen in melanoma and non-small cell lung cancer (NSCLC).”
The Phase I/II multicenter trial of OBX-115 is an open-label study investigating its safety and efficacy in patients with advanced or metastatic melanoma and NSCLC (NCT06060613).
References
1. Obsidian Therapeutics Announces FDA Fast Track Designation for OBX-115 for the Treatment of Advanced Melanoma. News release. Obsidian Therapeutics. July 9, 2024. Accessed July 12, 2024. https://obsidiantx.com/news-releases/obsidian-therapeutics-announces-fda-fast-track-designation-for-obx-115-for-the-treatment-of-advanced-melanoma/
2. Obsidian Therapeutics Announces Positive Clinical Data from OBX-115 in Patients with Advanced Melanoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. News release. Obsidian Therapeutics. May 23, 2024. Accessed July 12, 2024. https://obsidiantx.com/news-releases/obsidian-therapeutics-announces-positive-clinical-data-from-obx-115-in-patients-with-advanced-melanoma-at-the-2024-american-society-of-clinical-oncology-asco-annual-meeting/
3. Obsidian Therapeutics Announces Additional OBX-115 Safety and Efficacy Data in Oral Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. News release. Obsidian Therapeutics. June 3, 2024. Accessed July 12, 2024. https://obsidiantx.com/news-releases/obsidian-therapeutics-announces-additional-obx-115-safety-and-efficacy-data-in-oral-presentation-at-the-2024-american-society-of-clinical-oncology-asco-annual-meeting/
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
