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November 8, 2021

Calithera to suspend Phase II NSCLC trial due to lack of clinical benefit

The company estimates to save between $10m and $15m with the trial suspension.

Calithera Biosciences has reported that it will suspend the Phase II KEAPSAKE clinical trial of telaglenastat in stage IV non-squamous non-small cell lung cancer (NSCLC) due to a lack of clinical benefit.

This placebo-controlled, randomised, double-blind trial analysed the safety and anti-tumour activity of telaglenastat in combination with standard-of-care chemoimmunotherapy as front-line treatment for stage IV NSCLC patients.

These subjects had tumours with Kelch Like ECH Associated Protein 1 (KEAP1) or Nuclear factor-erythroid factor 2-related factor 2 (NRF2) mutations.

The trial had randomised a total of 40 subjects when it was unblinded on 27 October 2021.

The efficacy results, which included investigator-evaluated progression-free survival, did not show any clinical benefit.

Interim analysis findings of the trial also showed a reduced likelihood of an eventual positive outcome.

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No change in the safety profile between the two trial groups was observed.

Calithera voluntarily terminated the trial on obtaining approval from the KEAPSAKE Steering Committee members and have informed the US Food and Drug Administration of the latest development.

It estimates to save between $10m and $15m with the trial suspension.

With no current plans to advance the development of telaglenastat, the firm will now prioritise developing recently acquired targeted oncology therapies, notably sapanisertib and mivavotinib.

Calithera CEO Susan Molineaux said: “Our near-term clinical development plans include leveraging our clinical and biomarker expertise in the KEAP1/NRF2 pathway in the development of our mTORC1/2 inhibitor sapanisertib in squamous non-small cell lung cancer, as well as advancing the development of our SYK inhibitor mivavotinib in specific biomarker-defined populations of diffuse large B-cell lymphoma.

“In addition, we are continuing the development of our arginase inhibitor CB-280 for the treatment of cystic fibrosis.”

In July 2019, Calithera started a Phase I/II trial of telaglenastat plus Pfizer’s palbociclib (Ibrance) to treat cancer.

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