Phase 1 study of an STI with eryaspase in the treatment of pancreatic cancer continues

Jean-Baptiste André,

published on 04/19/2021 at 08:15 am

(Boursier.com) — Erytech Pharma announces the end of the recruitment of the first cohort, and the transition to the next and potentially last dose in an investigator-led Phase 1 clinical study, rESPECT (IST), with its flagship product eryaspase in first-line treatment pancreatic cancer.

The single-arm, escalating dose cohort Phase 1 clinical study, rESPECT IST (NCT04292743), evaluates the safety of eryaspase in combination with mFOLFIRINOX. This study, led by Dr. Marcus Noel (Associate Professor of Medicine at Georgetown University, Washington DC, USA), will enroll approximately 18 patients who have not received prior chemotherapy for the treatment of pancreatic cancer. locally advanced or metastatic. FOLFIRINOX is one of the two most common first-line chemotherapy regimens used in pancreatic cancer, despite its toxicity. The study started at the end of last year and the first cohort of three patients has now been recruited. After reviewing the safety data, the dose escalation committee concluded that no dose-limiting toxicity (TLD) was observed in the first cohort that received a therapeutic dose of 75 U / kg. eryaspase, and to date good tolerance to treatment has been observed in all patients. Interestingly, two of the three patients treated achieved a partial response and a significant decrease in the level of CA19-9, a tumor marker of certain types of pancreatic cancer, while in the third patient, the disease subsided. stabilized after the first cycle of treatment, underlines the biotech.

The study will now continue with the next cohort, with an increased dose to 100 U / kg eryaspase, the highest for this study and assumed to be the maximum tolerable dose (MTD), if no dose-limiting toxicity is observed. ‘is observed.

Dr. Marcus Noel comments: “The start of the study was very encouraging: eryaspase in combination with mFOLFIRINOX was well tolerated in the first cohort with a therapeutically relevant dose. It is still early and, well. that the study is not designed to assess the efficacy of eryaspase, the reductions in CA19-9 observed and the partial responses obtained in two out of three patients are promising “.

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