09 Oct 2018
Posted in Pharma
Copiktra Wins FDA Approval in FL, CLL, and SLL, but its commercial prospects are limited, says GlobalData
Following Verastem’s Copiktra (duvelisib) accelerated approval for the treatment of third-line follicular lymphoma (FL) in September 2018, as well as its standard approval for third-line chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL):
Arshad Ahad, Oncology and Hematology Analyst GlobalData, offers his view on its commercial prospects:
“Copiktra may have trouble gaining commercial traction in FL, and key opinion leader (KOL) excitement regarding this agent is low, as it will struggle to differentiate itself from the already marketed phosphoinositide 3-kinase (PI3K) inhibitors: Gilead Sciences’ Zydelig (idelalisib) and Bayer’s Aliqopa (copanlisib dihydrochloride).
“The FL accelerated approval was based on the overall response rate (ORR) of 42% from the DYNAMO Phase II study (NCT01882803). While truly accurate direct comparisons can only be made through head-to-head clinical trials, Copiktra’s ORR is lower than the 57% demonstrated by Zydelig and the 59% demonstrated by Aliqopa in their pivotal trials.
“However, Copiktra does also have some advantages in its favor. Zydelig only inhibits the delta isoform of PI3K, whereas Copiktra is a dual inhibitor of the delta and gamma isoforms, which is believed to provide a potential, additional mechanism to overcome the acquired resistance that can develop in response to PI3K-delta inhibition. Aliqopa is also a dual inhibitor (although against the delta and alpha isoforms) but Copiktra has a convenience advantage over that agent, as Copiktra is orally administered, as opposed to intravenous administration.
“The FDA label for Copiktra carries a boxed warning due to fatal and/or serious toxicities including infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. While this may further hamper its market potential, factors that may negate that include the fact that these warnings were already known from earlier studies, and that Copiktra is a third-line therapy, and so is aimed at a population that has few remaining options.
“Copiktra was originally being developed by Infinity Pharmaceuticals and AbbVie. AbbVie walked away from the partnership in 2016 upon seeing the weak Phase II results. Infinity licensed the drug to Verastem for no upfront payment, and $28M in milestones and single-digit royalties. Due to the FDA approval, Verastem will have to pay the bulk of the agreed-upon $28M. Given that Zydelig’s 2017 sales totaled $149M, down from peak-year sales of $168M in 2016, it is nonetheless possible that Verastem will recoup its investment despite Copiktra’s flaws.
Ahad concludes: “Verastem is expected to launch Copiktra within a week, and has stated a monthly list price of $11,800 for the agent. The company’s future plans for Copiktra include expanding its scope in FL, combinations with standard of care in aggressive non-Hodgkin’s lymphoma (NHL) subtypes, and possible combinations with CAR-T in the longer term. However, Copiktra’s toxicities will limit its possibilities within combination therapies. Overall, Copiktra faces a tough road ahead in terms of its commercial prospects. In addition to the challenges discussed above, Verastem has never launched a drug and will be directly competing against bigger players; Gilead and Bayer, which have a first-to-market advantage.”
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Notes to Editors
GlobalData (2018) B-Cell Non-Hodgkin’s Lymphoma (NHL): Opportunity Analysis and Forecasts to 2027, to be published
GlobalData (2018). Chronic Lymphocytic Leukemia (CLL) – Opportunity Analysis and Forecasts to 2027, to be published
GlobalData (2016) B-Cell Non-Hodgkin’s Lymphoma (NHL) – Opportunity Analysis and Forecasts to 2024, January 2016, GDHC018POA
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