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Spotlight on copanlisib and its potential in the treatment of relapsed/refractory follicular lymphoma: evidence to date.

ABSTRACT: The importance of the phosphatidylinositol-3-kinase (PI3K) pathway in cell survival and proliferation has made it an attractive target in cancer therapy. The development of small molecule inhibitors for the PI3K pathway continues to provide treatment alternatives across a range of malignancy types. Several agents, including idelalisib, copanlisib and duvelisib, not only inhibit the PI3K pathway, but also have effects on associated mechanisms including the ATK and mTOR pathways. The advent of PI3K-specific small molecular inhibitors has led to increased efficacy with avoidance of an excessive toxicity profile. Key enzymes of the PI3K pathway exhibit differing expression in tissue types and roles in tumor pathogenesis. Copanlisib (BAY 80-6946) is a pan-specific PI3K small molecule inhibitor for four key isoforms with increased activity against PI3K? and PI3K?, both important in B-cell malignancies. Follicular lymphoma is one of the most common indolent B-cell non-Hodgkin lymphomas worldwide. Follicular lymphoma like other indolent B-cell non-Hodgkin lymphomas is beleaguered by high relapse rates and the need for subsequent therapy options. Based on efficacy and a limited toxicity profile, copanlisib received accelerated US Food and Drug Administration approval for the treatment of adult patients with relapsed follicular lymphoma following two lines of therapy. Here, we review the development of copanlisib and the role of this agent in the treatment of follicular lymphoma.

SUBMITTER: Mensah FA

PROVIDER: S-EPMC6097514 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Spotlight on copanlisib and its potential in the treatment of relapsed/refractory follicular lymphoma: evidence to date.

Mensah Felix A FA Blaize Jean-Pierre JP Bryan Locke J LJ

OncoTargets and therapy 20180813

The importance of the phosphatidylinositol-3-kinase (PI3K) pathway in cell survival and proliferation has made it an attractive target in cancer therapy. The development of small molecule inhibitors for the PI3K pathway continues to provide treatment alternatives across a range of malignancy types. Several agents, including idelalisib, copanlisib and duvelisib, not only inhibit the PI3K pathway, but also have effects on associated mechanisms including the ATK and mTOR pathways. The advent of PI3 ...[more]

PMID: 30147333

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Project description:BackgroundCopanlisib was recently granted accelerated approval by the FDA for the treatment of adult patients with relapsed follicular lymphoma (FL) after 2 previous systemic therapies. It is important to assess the effect that this and other changes in the treatment landscape of relapsed FL have on a payer's budget to inform formulary decisions.ObjectiveTo assess the budget impact associated with the addition of copanlisib to a formulary as third- or higher-line treatment for adult patients with relapsed FL who have received at least 2 previous systemic therapies, from the perspective of a U.S. third-party payer.MethodsA budget impact model was developed over a 1-year horizon. The model considered a hypothetical population of 1 million people enrolled in a commercial health plan; patients with relapsed FL were identified based on epidemiology data. Treatments included copanlisib and approved and off-label therapies used for management of relapsed FL. Treatment distributions within the target population were based on a market research survey. Drug acquisition, administration, prophylaxis, and monitoring costs were based on prescribing information, clinical trials, literature, and expert opinion. All costs were inflated to 2017 U.S. dollars. Total costs were compared between 2 scenarios, 1 without and 1 with copanlisib on a formulary. A deterministic sensitivity analysis (DSA) was conducted to evaluate the robustness of the model.ResultsWithin the 1 million-member health care plan, 18 patients had relapsed FL and had received at least 2 previous systemic therapies. Over 1 year, the addition of copanlisib and an increase in the use of obinutuzumab + bendamustine (from 9.0% without copanlisib to 13.1% with copanlisib) and lenalidomide + rituximab (from 0.3% to 12.0%) were estimated to increase drug acquisition costs by $238,536, drug administration and prophylaxis costs by $3,565, and monitoring costs by $539. The increase in total budget was $242,641, corresponding to $0.02 per member per month; 21.8% of this increase was attributable to copanlisib, 12.9% to obinutuzumab + bendamustine, and 65.3% to lenalidomide + rituximab. Results were generally robust in the DSA.ConclusionsOver a 1-year period, the model found that the addition of copanlisib to a formulary resulted in a small increase in total budget of $242,641, corresponding to $0.02 per patient per month and taking into account a concurrent increase in the use of obinutuzumab + bendamustine and lenalidomide + rituximab. Therefore, adding copanlisib to a formulary appears to be an affordable option for payers. Further studies should be conducted to more comprehensively assess the clinical and economic implications of adding copanlisib to the treatment armamentarium of relapsed FL.DisclosuresThis study was funded by Bayer HealthCare Pharmaceuticals. The study sponsor was involved in study design, data interpretation. and data review. All authors contributed to the development of the manuscript and maintained control over the final content. Appukkuttan, Yaldo, Gharibo, and Babajanyan report employment with Bayer HealthCare Pharmaceuticals at the time of this study. Duchesneau, Zichlin, Bhak, and Duh report employment with Analysis Group, which received research funds from Bayer HealthCare Pharmaceuticals for work on this study. A synopsis of the current research was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting; April 23-26, 2018; Boston, MA.

Dataset Information

Spotlight on copanlisib and its potential in the treatment of relapsed/refractory follicular lymphoma: evidence to date.

Publications

Spotlight on copanlisib and its potential in the treatment of relapsed/refractory follicular lymphoma: evidence to date.

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