By Bhanvi Satija
MADRID, Oct 25 (Reuters) – Takeda Pharmaceutical plans to seek regulatory approval in Japan next year for its gastric cancer drug, after it extended overall survival and delayed disease progression in a late-stage study, a company executive told Reuters.
The drug, arcotatug tavatecan, or TAK-921, met both those main goals of the trial in patients with advanced gastric or gastroesophageal junction cancer who had received at least two prior therapies.
“We will leverage this data and file in Japan with an NDA next year,” PK Morrow, who leads oncology development for the Japanese drugmaker, said in an interview on Saturday at the European Society for Medical Oncology meeting in Madrid, referring to a new drug application.
Some analysts said the data was “a solid start” for Takeda’s more focused strategy for its oncology ambitions. The company is prioritizing development in lung and chest cancers, blood cancers and gastric cancer.
Median overall survival was 10.2 months for patients on the drug versus 6.9 months for those given doctor’s choice of chemotherapy, a difference that was deemed statistically significant.
Median progression-free survival, or the time it took for the disease to worsen, was 7.1 months for the Takeda drug versus 3.1 months in the control group, according to an independent review.
For a majority of patients in the study, Takeda’s drug was their third line of therapy, and for 30% of the patients it was a fourth or fifth treatment, Morrow said.
“Despite the fact that patients were so sick, they were able to tolerate the therapy. And secondly, we were still able to show significant benefit,” she said.
About 47% of patients on the drug had serious side effects, compared with about 56% of those on chemotherapy. The most common was low red blood cell count, or anemia, which affected about 20% of patients on the drug versus about 13% on chemotherapy.
The data from the study of 464 patients from Japan and China was presented on Friday at the ESMO meeting.
Severe nausea, vomiting and diarrhea were also less frequent with the Takeda drug, but one patient on the drug died suddenly from an unknown cause that was linked to the treatment, the company said.
Takeda’s drug targets a protein found on the surface of certain cancer cells called claudin 18.2, which was used as a biomarker for selecting patients most likely to benefit. The medicine belongs to a class of therapy known as antibody-drug conjugates. It delivers the cancer-killing agent exatecan directly to tumor cells.
Takeda’s trial enrolled patients with at least 75% of tumor cells expressing the target protein, but Morrow said the drug could be tested in patients with lower levels, given its tolerability profile.
A rival drug from AstraZeneca, which targets the same protein, met the overall survival goal in a global study but did not show benefit on progression-free survival.
Takeda licensed its drug from partner Innovent, which holds rights to the medication in China.
(Reporting by Bhanvi SatijaEditing by Bill Berkrot)
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