Post by icemandios on Apr 19, 2023 17:44:08 GMT
April 19, 2023 10:35 AM EDT
R&D
Pharma
In a leaked abstract, J&J's cell therapy appears to have dramatic benefits for multiple myeloma patients
Kyle LaHucik
Associate Editor
Patients taking Legend Biotech and Johnson & Johnson’s cancer cell therapy Carvykti had a 74% reduction in the risk of multiple myeloma progression or death, according to a leaked abstract from an upcoming medical meeting.
Legend and J&J have said they plan to seek approval for their CAR-T for earlier lines of treatment after snagging its first approval as a fifth-line option a year ago. In January, the companies announced in a news release that Carvykti beat the standard of care in an open-label trial testing the therapy as a second-line treatment for multiple myeloma.
The companies didn’t release detailed data at the time.
On Tuesday night, the abstract, which was expected to be published next month at the European Hematology Association and later at the American Society of Clinical Oncology annual meeting in June, was leaked in a rare instance of a medical conference abstract getting posted sooner than expected. A similar leak occurred at a breast cancer symposium last November, in which an accidental data drop of Arvinas’ drug sunk the biotech’s shares.
The highly anticipated Phase III data, since taken down by EHA, indicates a boon ahead for Carvykti. Not only could patients get access to the treatment sooner without needing to first exhaust multiple other treatment options, it may also mean that Carvykti has a leg up on Abecma, according to analysts.
A Legend spokesperson declined to comment on the leak, and a J&J spokesperson said the company is “unaware of how the data may have been leaked.” The data releases for EHA and ASCO were set to occur May 11 and May 25, respectively. An EHA spokesperson did not immediately respond to Endpoints News.
In the CARTITUDE-4 trial, 419 patients were randomized, split almost evenly among Carvykti and standard of care, which is made up of the immunotherapy pomalidomide, the corticosteroid dexamethasone and either bortezomib (a targeted chemo) or Darzalex (a monoclonal antibody).
According to Jefferies analyst Kelly Shi, who tracked down the data, Carvykti met the primary endpoint for reducing risk of progression or death by 74%, which came in at a p-value less than 0.0001, at 16 months of median follow-up. Median PFS was not yet reached, whereas the standard of care group experienced 12 months on that endpoint.
Jefferies and Cowen analysts tried to estimate the median PFS, putting it in the range of 35 to 40 months at final analysis. That range would be triple the standard of care, and more than double what BMS and 2seventy reported for Abecma earlier this year, which was 13.3 months, at a median follow-up of 18.6 months. There is no direct head-to-head data for the two cell therapies.
“This game-changing efficacy is highly encouraging for adoption in 2L in the short term (approval expected by YE23) and potentially 1L approval/uptake in the long term,” Cowen’s Yaron Werber wrote in an analyst note Tuesday night.
The data exceeded both Werber and Shi’s expectations, they wrote.
Carvykti, which is a one-time treatment, would be “game-changing” with median PFS at or above 30 months, per Cowen’s outreach to key opinion leaders.
Carvykti also appeared to have stronger rates of overall response (85% versus 67% for the comparator) and death rate (19% versus 22%) when compared with the standard of care. Grade 3 and 4 adverse events occurred in 97% of patients on Carvykti and 94% on the standard of care. In the 176 patients who received Carvykti before disease progression, 76% of them experienced cytokine release syndrome, a hyperactive immune response, but none were grade 4 or 5, the Jefferies analysts wrote.
If the data are confirmed at EHA and ASCO, Carvykti has the potential to reach more than $5 billion in peak sales, Jefferies analysts wrote. J&J reported $72 million in first-quarter sales for Carvykti and a total of $133 million in revenue in 2022, per an earnings update earlier this week.
R&D
Pharma
In a leaked abstract, J&J's cell therapy appears to have dramatic benefits for multiple myeloma patients
Kyle LaHucik
Associate Editor
Patients taking Legend Biotech and Johnson & Johnson’s cancer cell therapy Carvykti had a 74% reduction in the risk of multiple myeloma progression or death, according to a leaked abstract from an upcoming medical meeting.
The data, which emerged Tuesday night and have since been taken down, could put Carvykti ahead of competitor Abecma, a CAR-T developed by Bristol Myers Squibb and 2seventy bio, in earlier lines of treatment if and when it’s approved for those indications. The study’s results surprised analysts, with a Cowen analyst describing it as “game-changing efficacy,” and sent Legend’s shares $LEGN 14% higher after Wednesday’s opening bell. [And then ran up to 21.20% higher than Tues close, while JNJ barely reacted.]
Legend and J&J have said they plan to seek approval for their CAR-T for earlier lines of treatment after snagging its first approval as a fifth-line option a year ago. In January, the companies announced in a news release that Carvykti beat the standard of care in an open-label trial testing the therapy as a second-line treatment for multiple myeloma.
The companies didn’t release detailed data at the time.
On Tuesday night, the abstract, which was expected to be published next month at the European Hematology Association and later at the American Society of Clinical Oncology annual meeting in June, was leaked in a rare instance of a medical conference abstract getting posted sooner than expected. A similar leak occurred at a breast cancer symposium last November, in which an accidental data drop of Arvinas’ drug sunk the biotech’s shares.
The highly anticipated Phase III data, since taken down by EHA, indicates a boon ahead for Carvykti. Not only could patients get access to the treatment sooner without needing to first exhaust multiple other treatment options, it may also mean that Carvykti has a leg up on Abecma, according to analysts.
A Legend spokesperson declined to comment on the leak, and a J&J spokesperson said the company is “unaware of how the data may have been leaked.” The data releases for EHA and ASCO were set to occur May 11 and May 25, respectively. An EHA spokesperson did not immediately respond to Endpoints News.
In the CARTITUDE-4 trial, 419 patients were randomized, split almost evenly among Carvykti and standard of care, which is made up of the immunotherapy pomalidomide, the corticosteroid dexamethasone and either bortezomib (a targeted chemo) or Darzalex (a monoclonal antibody).
According to Jefferies analyst Kelly Shi, who tracked down the data, Carvykti met the primary endpoint for reducing risk of progression or death by 74%, which came in at a p-value less than 0.0001, at 16 months of median follow-up. Median PFS was not yet reached, whereas the standard of care group experienced 12 months on that endpoint.
Jefferies and Cowen analysts tried to estimate the median PFS, putting it in the range of 35 to 40 months at final analysis. That range would be triple the standard of care, and more than double what BMS and 2seventy reported for Abecma earlier this year, which was 13.3 months, at a median follow-up of 18.6 months. There is no direct head-to-head data for the two cell therapies.
“This game-changing efficacy is highly encouraging for adoption in 2L in the short term (approval expected by YE23) and potentially 1L approval/uptake in the long term,” Cowen’s Yaron Werber wrote in an analyst note Tuesday night.
The data exceeded both Werber and Shi’s expectations, they wrote.
Carvykti, which is a one-time treatment, would be “game-changing” with median PFS at or above 30 months, per Cowen’s outreach to key opinion leaders.
Carvykti also appeared to have stronger rates of overall response (85% versus 67% for the comparator) and death rate (19% versus 22%) when compared with the standard of care. Grade 3 and 4 adverse events occurred in 97% of patients on Carvykti and 94% on the standard of care. In the 176 patients who received Carvykti before disease progression, 76% of them experienced cytokine release syndrome, a hyperactive immune response, but none were grade 4 or 5, the Jefferies analysts wrote.
If the data are confirmed at EHA and ASCO, Carvykti has the potential to reach more than $5 billion in peak sales, Jefferies analysts wrote. J&J reported $72 million in first-quarter sales for Carvykti and a total of $133 million in revenue in 2022, per an earnings update earlier this week.
The cell therapy has run into supply issues in the past because of a complex and timely manufacturing process that requires taking cells from the patient, engineering them and then infusing them back into the patient. Novartis, a longtime maker of CAR-T therapies, was tapped last week to help beef up manufacturing.
[Tues close was 52.24. Weds open 58.21. 10day avg vol is 720,390. Weds vol at 13:45 is 6,701,454. Now at 62.21.]
