Study Launches to Investigate Effectiveness of Potential First-in-Class Lung Cancer Drug

The first patient was dosed in a phase 2 trial studying the efficacy of sapanisertib in patients with NRF2-mutant relapsed/refractory lung cancer.

A patient has been dosed in a phase 2 trial, kicking off the study of sapanisertib (CB-228) for patients with relapsed/refractory NRF2 (NFE2L2)-mutant squamous non-small cell lung cancer that has progressed on two or more prior therapies, according to Calithera Biosciences, the manufacturer of the agent.

“Sapanisertib has the potential to be a first-in-class treatment for patients with NRF2-mutated squamous lung cancer, a patient population with poor prognosis and high unmet need,” Susan Molineaux, president and CEO of Calithera, said in a press release. “This study is designed to further validate the NRF2 mutation as a selection biomarker, and we plan to share data from the trial by the first quarter of 2023.”

The drug targets certain survival mechanisms in cancer cells that have NRF2 mutations, which can be found in a range of solid tumors, and about 15% of squamous non-small cell lung cancers.

Researchers on the trial plan to enroll 50 patients. Thirty patients with NFEL2L2 mutations will be in Group A, which will then be divided into two groups: half the patients will receive 3 mg per day of sapanisertib, while the other half will receive 2 mg, twice a day. The remaining 20 enrolled patients (those whose disease is NFE2L2-wildtype) will be assigned to Group B, which will be split into two groups: those who will get 3 mg of sapanisertib once a day, and those who will receive 2 mg, twice per day.

The main goal of the study is to determine an overall response rate, which is the percentage of patients whose disease completely disappears (known as a complete response) or shrinks (known as a partial response) 36 months after treatment. Another priority for the study will be analyzing side effects.

Secondary outcomes the researchers will consider include duration of response at the 36-month mark; progression-free survival (time from treatment until disease worsens) at 36 months and overall survival (percentage of patients who are still alive) at 36, 12 and six months.

Recruitment in the study is ongoing, and patients should discuss eligibility with their providers.

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