In a surprising turn of events, Cargo Therapeutics, a biotech company specializing in CAR T therapies, has announced the discontinuation of its mid-stage clinical trial for its lead candidate and a significant reduction in its workforce. The decision comes after an ad hoc analysis prompted by recent safety concerns revealed less favorable outcomes than previously observed. Analysts from Jefferies expressed disappointment, noting that the Phase I study had shown promising results with a 50% complete response rate and multi-year durability. However, the Phase II trial for patients with large B cell lymphoma (LBCL) did not replicate these positive findings, leading to the company's strategic reassessment.
Details of the Announcement
In the heart of California's biotech hub, San Carlos-based Cargo Therapeutics made headlines on a late Wednesday evening. The company disclosed that it was halting the FIRCE-1 Phase II trial for firicabtagene autoleucel (firi-cel), an autologous CD22 CAR T cell therapy. This decision followed an impromptu analysis triggered by recent safety incidents. The analysis concluded that the therapy did not present a competitive benefit-risk profile for patients with relapsed or refractory LBCL who had previously undergone CD19 CAR T cell therapy.
The data from the FIRCE-1 study showed an overall response rate of 77% and a complete response rate of 43%. However, the durability of the complete response at three months was only 18%, significantly lower than the earlier Phase I study. Additionally, 18% of participants experienced severe immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome, a toxicity linked to CAR T therapies. Although Cargo did not explicitly state it was shelving firi-cel, no further development plans were mentioned.
Despite this setback, Cargo remains committed to advancing its pipeline. The company plans to move forward with CRG-023, a tri-specific CAR T therapy, into a Phase I dose escalation study, with enrollment expected to begin in the second quarter of this year. Furthermore, Cargo will continue developing its allogeneic platform and evaluating strategic options. With $368.1 million in cash reserves as of December 31, 2024, and a reduced workforce, the company anticipates extending its financial runway into mid-2028.
From a journalist's perspective, this announcement underscores the unpredictable nature of clinical trials and the challenges faced by biotech companies in bringing innovative therapies to market. It highlights the importance of rigorous safety assessments and the need for continuous evaluation of treatment efficacy. While disappointing, such setbacks are part of the scientific process, ultimately driving advancements in patient care and therapeutic approaches.