Enhertu picks up another win for AstraZeneca and Daiichi Sankyo, joining the priority review lane for gastric cancer
Five months after Enhertu received twin breakthrough therapy designations, AstraZeneca and Daiichi Sankyo are one step closer to nabbing another approval for their potential blockbuster drug.
The companies announced Wednesday morning that their billion-dollar antibody-drug conjugate has received priority review for HER2 positive metastatic gastric cancer. Already approved in the US for third-line metastatic breast cancer patients that are HER2 positive, Enhertu’s gastric cancer PDUFA date is scheduled for the first quarter of 2021.
Wednesday’s news stems from the positive Phase II data that AstraZeneca and Daiichi Sankyo published in NEJM back in June, the companies said. In the 187-person trial, which randomized Enhertu 2 to 1 against physician’s choice, 51% of the patients in the drug arm reported an objective response compared to 14% in the control. Enhertu also saw longer overall survival rates, with a median of 12.5 months as opposed to 8.4 months.
Antoine Yver, Daiichi Sankyo’s global oncology chief, noted in a statement that those results “are unprecedented as they represent the first time a HER2 directed medicine has demonstrated an improvement in survival following chemotherapy and HER2 treatment in the metastatic settings.”
The priority review is just another in a string of successful steps for this partnership. Within the span of a week in May, Enhertu picked up BTDs in both gastric cancer and non-small cell lung cancer, setting up two additional indications for the HER2-fighting drug. That followed a rapid approval in breast cancer last December as the FDA OK came just 8 months after AstraZeneca and Daiichi Sankyo signed their collaboration agreement.
AstraZeneca paid a hefty price at the time, throwing close to $7 billion to their partners on this drug, including $1.35 billion upfront. The approval came well ahead of schedule as well — it had originally been scheduled for sometime in the second quarter of 2020.
Enhertu now moves even farther ahead of a rival in Roche’s Kadcyla, which flopped 5 years ago in a Phase II/III trial in second-line patients. That trial ultimately proved a reason for slowing sales of the drug, which once held the $2 billion-plus promise that Enhertu now holds but has only peaked around $1 billion.
Pascal Soriot is likely eager to put another feather in his cap with this deal bearing more fruit, as he has throughout his tenure tried to beef up AstraZeneca’s cancer division through other programs like Imfinzi and Tagrisso. Analysts predict peak sales can surpass $2 billion, and Daichii Sankyo has said in the past it expects to reach the $4.5 billion mark.