Drug Overview
Aliqopa (copanlisib; Bayer) is a small molecule phosphoinositide 3-kinase (PI3K) inhibitor with high selectivity for the p110-alpha/delta catalytic subunits. The PI3K pathway is crucial for normal B-cell development, and is subverted by follicular lymphoma (FL) to promote survival and growth. The p110-delta subunit is particularly important for the survival of indolent NHLs, and p110-delta as well as p110-alpha are hypothesized to be important for the survival of aggressive NHLs.
With the accelerated approval of Aliqopa for the third-line treatment of FL, Bayer positioned its PI3K inhibitor in direct competition with Zydelig (idelalisib; Gilead), the first PI3K inhibitor approved for FL. Bayer is also investigating Aliqopa in earlier lines of treatment and as a combination therapy with rituximab in the pivotal Phase III CHRONOS-2 (ClinicalTrials.gov identifier: NCT02369016), CHRONOS-3 (ClinicalTrials.gov identifier: NCT02367040), and CHRONOS-4 (ClinicalTrials.gov identifier: NCT02626455) trials.
Analyst Outlook
With the accelerated approval of Aliqopa (copanlisib; Bayer) for the third-line treatment of follicular lymphoma (FL), Bayer positioned its phosphoinositide 3-kinase (PI3K) inhibitor in direct competition with Zydelig (idelalisib; Gilead), the first PI3K inhibitor approved for FL. Bayer is also investigating Aliqopa in earlier lines of treatment and as a combination therapy with rituximab in the pivotal Phase III CHRONOS-2 (ClinicalTrials.gov identifier: NCT02369016), CHRONOS-3 (ClinicalTrials.gov identifier: NCT02367040), and CHRONOS-4 (ClinicalTrials.gov identifier: NCT02626455) trials. Indication for use with standard-therapy rituximab and expansion into earlier treatment settings would give Aliqopa an advantage over Zydelig, which failed to move beyond its single approval in third-line FL. In addition, Aliqopa may have to compete with PI3K inhibitors Copiktra (duvelisib; Verastem/Infinity/Yakult Honsha Co), INCB050465 (Incyte), and umbralisib (TG Therapeutics), which are currently in late-phase development for FL. However, Aliqopa’s commercial outlook in this indication may surpass other PI3K inhibitors due to its range of activity. Aliqopa is the only drug in its class that is a strong inhibitor of PI3K-alpha in addition to PI3K-delta, which could prove useful as PI3K-alpha is hypothesized to play a more prominent role as indolent non-Hodgkin’s lymphomas (NHLs) become more aggressive.
Aliqopa (copanlisib; Bayer) is a small molecule phosphoinositide 3-kinase (PI3K) inhibitor with high selectivity for the p110-alpha/delta catalytic subunits. The PI3K pathway is crucial for normal B-cell development, and is subverted by follicular lymphoma (FL) to promote survival and growth. The p110-delta subunit is particularly important for the survival of indolent NHLs, and p110-delta as well as p110-alpha are hypothesized to be important for the survival of aggressive NHLs.
With the accelerated approval of Aliqopa for the third-line treatment of FL, Bayer positioned its PI3K inhibitor in direct competition with Zydelig (idelalisib; Gilead), the first PI3K inhibitor approved for FL. Bayer is also investigating Aliqopa in earlier lines of treatment and as a combination therapy with rituximab in the pivotal Phase III CHRONOS-2 (ClinicalTrials.gov identifier: NCT02369016), CHRONOS-3 (ClinicalTrials.gov identifier: NCT02367040), and CHRONOS-4 (ClinicalTrials.gov identifier: NCT02626455) trials.
Analyst Outlook
With the accelerated approval of Aliqopa (copanlisib; Bayer) for the third-line treatment of follicular lymphoma (FL), Bayer positioned its phosphoinositide 3-kinase (PI3K) inhibitor in direct competition with Zydelig (idelalisib; Gilead), the first PI3K inhibitor approved for FL. Bayer is also investigating Aliqopa in earlier lines of treatment and as a combination therapy with rituximab in the pivotal Phase III CHRONOS-2 (ClinicalTrials.gov identifier: NCT02369016), CHRONOS-3 (ClinicalTrials.gov identifier: NCT02367040), and CHRONOS-4 (ClinicalTrials.gov identifier: NCT02626455) trials. Indication for use with standard-therapy rituximab and expansion into earlier treatment settings would give Aliqopa an advantage over Zydelig, which failed to move beyond its single approval in third-line FL. In addition, Aliqopa may have to compete with PI3K inhibitors Copiktra (duvelisib; Verastem/Infinity/Yakult Honsha Co), INCB050465 (Incyte), and umbralisib (TG Therapeutics), which are currently in late-phase development for FL. However, Aliqopa’s commercial outlook in this indication may surpass other PI3K inhibitors due to its range of activity. Aliqopa is the only drug in its class that is a strong inhibitor of PI3K-alpha in addition to PI3K-delta, which could prove useful as PI3K-alpha is hypothesized to play a more prominent role as indolent non-Hodgkin’s lymphomas (NHLs) become more aggressive.
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OVERVIEW
LIST OF FIGURES
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