ALRN - Aileron drug fails to beat placebo in reducing chemo toxicities in lung cancer patients in trial

Aileron Therapeutics ( NASDAQ: ALRN ) said it plans to stop further enrollment in a phase 1b study of ALRN-6924 after the drug did not reduce chemo induced toxicities compared to placebo, in patients with lung cancer.

The drug, however, helped the patients stay on chemotherapy treatment longer, compared to placebo.

The company reported interim data from its phase 1b chemoprotection trial of ALRN-6924 versus placebo in patients with advanced p53-mutated non-small cell lung cancer (NSCLC) undergoing treatment with chemotherapies first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. The interim analysis consisted of 20 patients.

The company said patients treated with ALRN-6924 were able to stay on chemotherapy longer, completing 93% of the first 4 cycles of carboplatin/pemetrexed administered, compared to 78% on placebo.

However, this imbalance of completed cycles between the treatment groups may have introduced a bias against ALRN-6924 on the study's main goal, the company noted in a June 29 press release.

This was reflected in progression free survival (PFS), which was 4.6 months for those in the ALRN-6924 group versus 3.2 months for those on placebo.

"We are very encouraged by the finding that ALRN-6924-treated patients were able to complete more cycles of chemotherapy in the NSCLC trial, but unfortunately it also appears that this may have worked against us given the nature of the exploratory composite primary endpoint. The more cycles patients completed the more opportunity they had to experience toxicities," said Aileron President and CEO Manuel Aivado.

The main goal was proportion of treatment cycles free of Grade ?3 neutropenia (a condition where body has too few neutrophils, a type of white blood cells); thrombocytopenia (low platelet count); anemia, blood transfusions, and use of growth factors, and dose reductions or dose delays within the first four cycles of therapy.

The company noted that patients on ALRN-6924 showed 56% of cycles free from these Grade ?3 blood toxicities and related events, compared to 50% on placebo.

The company said it wants to apply learning from the trial into a phase 1b trial in breast cancer.

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