CAR T-cell therapies for hematologic cancers are a promising development that most oncologists expect to use in their practice, according to a new Medscape survey of clinicians.
In the survey, all the respondents said they believed that products manufactured from patients’ chimeric antigen receptor (CAR) T cells would prove to be effective in the long term, and 95% said the products would prove to be safe.
Not all of the 41 oncologists who responded to the Medscape email query in August were familiar with the therapies, although half said they are affiliated with a hospital that is approved as a CAR T-cell therapy center.
Medscape first asked whether the respondents knew of the two therapies currently under review at the US Food and Drug Administration (FDA): tisagenlecleucel (previously known as CTL019; developed by Novartis); and Kite Pharma’s axicabtagene ciloleucel (KTE-C19).
Thirty-seven percent had some familiarity with tisagenlecleucel, and about 15% knew basic information about the product. More than a quarter knew the name, but 37% had never heard of tisagenlecleucel. Forty-four percent had never heard of axicabtagene ciloleucel, while 22% had heard the name, and 34% had some familiarity with it.
The respondents then were given trial information sourced from the manufacturers that showed that 83% of patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia who were treated with tisagenlecleucel achieved complete remission. For patients with refractory aggressive B-cell non-Hodgkin lymphoma who were treated with axicabtagene ciloleucel, the complete response rate was 39%.
After reading the trial data, 90% of the oncologists said CAR T-cell therapies would be important or very important in hematologic malignancies.
All of the respondents ultimately agreed that, on the basis of available data, the therapies will prove to be effective in the long term, and 83% said it would be applicable in their practice if approved.
“Excited”
“This is a wonderful, novel therapeutic, which is not only effective for refractory patients but also can cure patients without the need of irradiation,” said one pediatric oncologist, who has been practicing for more than 25 years. “It also avoids many transplant-related toxicities,” he said, adding that “short-term toxicities are manageable.”
Another oncologist, noting that his hospital was selected by Novartis as a regional center for the treatment, said, “The head of the program here has discussed the data with me extensively ― I am excited about the prospects for CAR T.”
Seventy-five percent of the respondents agreed that the benefits outweigh the risks for patients for whom all other options have been exhausted, but a majority also said the therapies should only be available in centers that have been approved to offer it. Fewer than 3 in 10 said they would be very comfortable treating CAR T adverse events.
Although safety has been a concern regarding the drugs, 95% said they believe the therapy will be safe in the long term.
“Experience is key, and as it is used more, one will obtain a higher degree of confidence,” commented one hematologist.
A majority of the clinicians said they thought CAR T would eventually be used earlier in the disease process. Almost as many agreed that there was a need for reliable manufacturing and production processes.
Almost half of the respondents envision that CAR T will come to replace stem cell transplants, but access to the therapy would be limited to appropriate candidates. A third said the cost of CAR T would be prohibitive.
The manufacturers have not discussed pricing for the therapies, but industry watchers have estimated that costs will range from $300,000 to $500,000.
An FDA advisory panel unanimously backed approval of tisagenlecleucel on July 12, which suggests US approval may not be far off.
For more news, join us on Facebook and Twitter
Tidak ada komentar:
Posting Komentar