Phase 3 CHRONOS-3 Study Meets Primary End Point for Indolent Non-Hodgkin’s Lymphoma

October 14, 2020

The study is evaluating copanlisib (Aliqopa) in combination with rituximab (Rituxan) in patients with indolent non-Hodgkin’s lymphoma who have relapsed after 1 or more prior lines of rituximab-containing therapy.

The phase 3 CHRONOS-3 study, evaluating copanlisib (Aliqopa) in combination with rituximab (Rituxan) in patients with indolent non-Hodgkin’s lymphoma (iNHL) who have relapsed after 1 or more prior lines of rituximab-containing therapy, has met its primary end point of prolonged progression-free survival (PFS), according to Bayer, the developer of the agent.

Specifically, the study predominantly consisted of patients with follicular lymphoma and marginal zone lymphoma, as well as patients with small lymphocytic lymphoma and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia.

“Indolent forms of non-Hodgkin’s lymphoma are a heterogenous group of malignancies characterized by a chronic pattern of remissions and recurrences. For iNHL patients with disease progression who are in need of treatment, there are few approved treatment options,” Scott Z. Fields, MD, senior vice president and head of Oncology Development at Bayer, said in a press release. “The positive results from CHRONOS-3 demonstrate the potential clinical benefit of copanlisib in combination with rituximab, to address the unmet medical need in these patients.”

The phase 3, randomized, double-blind, placebo-controlled trial is evaluating whether copanlisib in combination with rituximab is superior to placebo plus rituximab in extending PFS in patients with relapsed iNHL who have received at least 1 prior rituximab product. Of note, patients included in the trial must have relapsed after the last rituximab-containing therapy and either had a treatment-free interval of 12 months or greater after completion of the last rituximab-containing treatment, been unwilling to receive chemotherapy, or have chemotherapy be contraindicated due to age, comorbidities, and/or residual toxicity.

Overall, the study enrolled 458 patients. Thus far, the safety observed in the trial has been generally consistent with previously published data on the individual components of the combination and no new safety signals have been identified.

Bayer indicated that results from the phase 3 CHRONOS-3 trial will be presented at an upcoming scientific congress. Moreover, the company plans to discuss the data from the study with health authorities worldwide.

Notably, copanlisib was approved in the US under accelerated approval in 2017 for the treatment of adult patients with relapsed follicular lymphoma who have received at least 2 prior systemic therapies. The accelerated approval was granted based on the overall response rate (ORR) observed in the open-label, single-arm, multicenter, phase 2 CHRONOS-1 clinical trial.

In total, the study enrolled 142 patients, including 104 patients with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least 2 prior treatments.

The phase 2 study demonstrated an ORR of 59% (n = 61; 95% CI, 49-68), including 14% (n = 15) with a complete response (CR). Moreover, in the updated 2-year follow-up analysis, copanlisib showed an ORR of 59% (n = 61; 95% CI, 49-68), including 20% with a CR (n = 21). However, continued approval for this indication will be contingent upon verification and description of clinical benefit in a confirmatory trial.

Reference:

Aliqopa™ (copanlisib) in Combination With Rituximab Meets Primary Endpoint in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma [news release]. Whippany, NJ. Published October 14, 2020. Accessed October 14, 2020. https://bayer2019tf.q4web.com/news/news-details/2020/Aliqopa-copanlisib-in-Combination-With-Rituximab-Meets-Primary-Endpoint-in-Patients-With-Relapsed-Indolent-Non-Hodgkins-Lymphoma/default.aspx