13 April 2021 - - Results from the randomized, double-blind, placebo-controlled Phase III trial CHRONOS-3 show a significant improvement in progression-free survival with the investigational combination of Aliqopa (copanlisib) and rituximab given intravenously in patients with relapsed indolent non-Hodgkin's Lymphoma compared to the combination of rituximab and placebo, German healthcare company Bayer said.

After a median follow-up of 19.2 months, patients treated with this combination had a median PFS of 21.5 months (95% CI 17.9, 33.0) versus 13.8 months in patients treated with rituximab and placebo (95% CI 10.2, 17.5), (HR=0.52, p=0.000002).

No new safety signals were identified for Aliqopa in the combination arm of the study.

The data will be presented in a Clinical Trials Plenary Session on April 10 at the virtual American Association for Cancer Research annual meeting 2021 and simultaneously published in The Lancet Oncology.

CHRONOS-3 is a Phase III randomized, double-blind, placebo-controlled trial with the objective to evaluate whether Aliqopa in combination with rituximab is superior to placebo plus rituximab in extending PFS in patients with relapsed iNHL following at least one prior rituximab-containing therapy.

Patients who had a progression-free and treatment-free interval of at least 12 months after completion of the last rituximab-containing regimen or patients unwilling/unfit or for who chemotherapy was contraindicated by reason of age, co-morbidities and/or residual toxicity were included.

In 2017, Aliqopa was approved for the treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies based on the results of a single-arm, multicenter, Phase II clinical trial (CHRONOS-1).

Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

Bayer is in discussions with health authorities worldwide regarding the data from CHRONOS-3.

In addition to the primary endpoint of PFS, data on the secondary endpoints of ORR and complete response rate will also be presented.

Best ORR for the combination of Aliqopa and rituximab was 80.8% (95% CI 76, 85) versus 47.7% (95% CI 40, 56) for rituximab and placebo (p