AstraZeneca, Daiichi Sankyo get FDA breakthrough therapy status for gastric cancer drug

AstraZeneca and Daiichi Sankyo have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its Enhertu to treat patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

Enhertu, a HER2-directed antibody drug conjugate (ADC), is being studied under a comprehensive development programme to assess the efficacy and safety of the monotherapy across multiple HER2-driven cancers such as breast, gastric and lung cancers.

The current designation was provided based on results from the registrational phase II DESTINY-Gastric01 and the data from the phase I trial.

DESTINY-Gastric01 is a registrational, phase II, open-label and multi-centre study evaluating the safety and efficacy of Enhertu in a primary cohort of 188 patients from Japan and South Korea with HER2-expressing, advanced gastric cancer or gastroesophageal junction adenocarcinoma.

According to the company, the patients treated with Enhertu showed a statistically significant and clinically meaningful improvement in objective response rate (ORR) and overall survival (OS) against patients treated with investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy).

The ORR is the primary endpoint, while OS is a crucial secondary endpoint in the trial.

AstraZeneca R&D oncology executive vice president José Baselga said: “Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines.”

In March 2018, Enhertu secured SAKIGAKE designation from Japan’s Ministry of Health, Labour and Welfare (MHLW) for potential use in the same HER2-positive gastric cancer patient population. It was also submitted to the MHLW for approval.

Enhertu secured breakthrough therapy designation from the FDA for HER2-positive metastatic breast cancer in 2017, as well as received approval in December 2019.

In March 2019, AstraZeneca and Daiichi Sankyo have collaborated to jointly develop and commercialise Enhertu across the world, except in Japan where Daiichi Sankyo has exclusive rights.

Daiichi Sankyo will alone take the responsibility for manufacturing and supply of Enhertu.

Daiichi Sankyo oncology R&D and oncology development global head senior vice president Gilles Gallant said: “DESTINY-Gastric01 represents the first randomised trial of Enhertu to demonstrate clinically meaningful and statistically significant results, including objective response and survival increases compared to physician’s choice of chemotherapy.”

Recently, AstraZeneca has entered into an agreement with Oxford University for the development of a vaccine to prevent Covid-19 disease.

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