In Secura’s hands PI3K delta lives on

After the withdrawals of several drugs with activity against the delta isoform of PI3K one such inhibitor, Verastem’s Copiktra, was sold to the private US biotech Secura Bio. Now Secura is following through on its promise to investigate Copiktra in a brand new use, moving to initiate the phase 3 Terzo trial in relapsed/refractory nodal T-cell lymphoma in December, according to a new entry on clinicaltrials.gov. Copiktra and Gilead’s Zydelig are the only remaining PI3K inhibitors still approved for haematological cancers, though sales are minimal and a US adcom voted against Copiktra’s continued use in CLL in September 2022. Meanwhile, Zydelig and Copiktra’s follicular lymphoma approvals were withdrawn, as were those of Bayer’s Aliqopa and TG Therapeutics’ Ukoniq. Secura bought Copiktra from Verastem for $70m in 2020, since when the phase 2 Primo study in peripheral T-cell lymphoma yielded a 49% ORR among 101 median fourth-line patients. New listings on clinicaltrials.gov also reveal that this month Merus will begin a second phase 3 study of the anti-EGFR x LGR5 bispecific petosemtamab, in first-line head and neck cancer as part of a Keytruda combo. The first petosemtamab phase 3, as monotherapy in second-line disease, began in June.

Phase 3 studies newly listed on clinicaltrials.gov

Source: OncologyPipeline.