by Thomas Meek
LONDON, Aug 18 (APM) - The expansion of the ZUMA-1 study for Kite Pharma's CAR-T therapy axicabtagene ciloleucel (axi-cel) to include patients in Europe is key to the drug's success in the region, the company's chief medical officer has told APM.
The trial has been ongoing in the U.S., though European inclusion in ZUMA-1 is important as it will raise awareness of the drug in Europe, meaning doctors are more likely to prescribe the product once it is approved, David Chang said in an emailed interview.
“In the U.S., awareness of CAR-T therapy, which is a critical component for adoption, more than doubled from a year ago,” said Chang.
Chang said the first patient in the expansion has been treated in a safety expansion cohort at the Academic Medical Centre in Amsterdam and that additional sites across the EU are currently enrolling patients.
“This was the first time axi-cel has been used in the EU and signifies an important step in making this transformative therapy available patients in the EU and worldwide," said Chang.
“We know from research that health care providers who are aware of CAR-T therapy are more likely to refer patients to CAR-T therapy or prescribe CAR- T. Once approved, we expect centres will reach out to patients they’ve identified as candidates for axi-cel, and we will be fully prepared to process and deliver the cell orders.”
Axi-cel is under review in Europe as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplant.
The assessment of the drug is accelerated under the European Medicines Agency's PRIME initiative.
Kite expects European approval and launch in 2018 for its CAR-T therapy axicabtagene ciloleucel, Chang told APM.
'Historic milestone'
CAR-T is a new form of cancer immunotherapy that involves removing and enhancing a patient's own T cells to attack foreign cancer cells.Kite is one of the companies leading the way in the field along with Novartis and Juno, which are also competing among potential early entrants onto market with a CAR-T therapy.
Kite appears to be ahead of the competition in Europe, where it was the first to file a CAR-T therapy in July this year (APMMA 54134).
Chang described the filing as a “historic milestone not just for Kite, but also for the entire field of CAR-T therapy”.
“The application underscores our commitment to providing a potentially curative therapy to patients worldwide with refractory, aggressive non Hodgkin's lymphoma (NHL) who previously had no other treatment options.”
Explaining the company's decision to focus initially on DLBCL, he said it is the most common form of aggressive NHL, primarily to meet the high unmet need for patients who have not responded to other forms of therapy.
“DLBCL accounts for approximately 35% of incidence and approximately 50% of deaths in NHL.”
Combination potential
The drug also has potential as part of combination therapies in cancer, said Chang, who highlighted the ZUMA-6 trial, with is a Phase Ib/II trial evaluating the safety and efficacy of axi-cel in combination with atezolizumab, Genentech’s anti-PD-L1 cancer immunotherapy, in DLBCL.“This study is a core element of our broad strategy to optimize axi-cel treatment outcomes. We anticipate Phase I data from this study to be presented by the end of 2017,” said Chang.
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