Atara reports patient death in cancer treatment study
Atara Biotherapeutics, a South San Francisco-based drug development company with major operations in Thousand Oaks, reported to the U.S. Food and Drug Administration on Feb. 18 that a patient died in one of its Phase 1 trials.
The patient, who was being treated at a Memorial Sloan Kettering Cancer Center location in New York, suffered a “fatal serious adverse event,” Atara said in a news release.
So far, no correlation between the patient’s death and Atara’s Phase 1 trial has been established, but Sloan Kettering is investigating the death, Atara said.
The patient had a history of multiple malignancies and other comorbidities and was undergoing treatment for advanced recurrent mesothelioma.
“The safety of every patient participating in studies we are funding or conducting is of the utmost priority for Atara,” Jakob Dupont, Atara’s head of global research & development at Atara, said in a statement. “Clinical evaluation of the case remains ongoing, and we are working closely with investigators at [Sloan Kettering] … to establish the underlying causes of the event. We anticipate providing a further update in the coming weeks.”
Atara’s Phase 1 trial is being conducted by Sloan Kettering and is a dose-escalation clinical study of autologous mesothelin CAR T, or ATA2271. The treatment is a T-cell therapy targeting mesothelin in patients with malignant pleural mesothelioma.
The median survival of treated patients with malignant pleural mesothelioma is nine to 17 months, Atara said.
The first six patients in the trial enrolled in the two lowest dose cohorts. Within these two cohorts, no dose limiting toxicities have been reported to date, Atara said.
The deceased was the first patient in a third, higher-dose cohort.
The company did not suspend the ongoing trial, but said Sloan Kettering has “voluntarily paused” the enrollment of new patients in the study while the death is investigated. Atara has notified the FDA that it agrees with this approach.
Atara added that the temporary pause in the ATA2271 study enrollment does not impact the work currently underway on ATA3271, a separate CAR-T therapy targeting mesothelin for patients with advanced mesothelioma.
Atara’s stock dropped about 11% on Feb. 18 after the news of the patient’s death, to close at $12.07. The shares regained most of that loss in the following days and closed on Feb. 22 at $13.22.