We are currently underway with a proof-of-concept Phase 1b study evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced bone marrow toxicities, such as severe anemia, thrombocytopenia and neutropenia, in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with topotecan.
In October, we announced new positive clinical results from our ongoing Phase 1b trial demonstrating that treatment with ALRN-6924 24 hours prior to second-line topotecan administration resulted in a protective effect against severe anemia, thrombocytopenia and neutropenia in patients with p53-mutated small cell lung cancer (SCLC). With these data, ALRN-6924 has achieved clinical proof of concept. The results were featured in a late-breaking poster presentation entitled, “Prevention of Chemotherapy-induced Myelosuppression in SCLC Patients Treated with Dual MDM2/MDMX Inhibitor ALRN-6924” at the 32nd EORTC-NCI-AACR Annual (ENA 2020) Symposium on Molecular Targets and Cancer Therapeutics. (Link here for poster and here for press release.)
We continue to enroll patients in a schedule optimization part of the Phase 1b trial intended to determine whether ALRN-6924 given six hours prior to topotecan could be an alternative dosing schedule that could provide patients and healthcare providers with additional flexibility of when to administer ALRN-6924 before topotecan. We expect to report final results from the Phase 1b trial, including data from the 6 hour-schedule, in the first quarter of 2021.
We expect to initiate registration programs for ALRN-6924 in non-small cell lung cancer in the second half of 2021 and in a gastrointestinal cancer indication in 2022, subject to the results of a healthy volunteer study planned to initiate in the fourth quarter of 2020, and the final data from the Phase 1b study expected in the first quarter of 2021.
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