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AZ, Daiichi Sankyo’s Enhertu set fair for filing in gastric cancer

Improved overall survival when compared to chemotherapy

AZ Daiichi

AstraZeneca and Daiichi Sankyo say new Enhertu data in gastric cancer could be enough to file for approval, potentially adding another indication to its label.

Top-line results from the phase 2 DESTINY-Gastric01 study show that the antibody-drug conjugate (ADC) improved overall survival compared to chemotherapy in patients with previously-treated, HER2 positive metastatic gastric cancer.

The results back up the findings of an earlier phase 1 trial published last year in The Lancet, according to the two drugmakers, who say they will now start discussing the data with the Japanese drug regulator, as well as health authorities in other countries, about possible marketing applications.

Enhertu (trastuzumab-deruxtecan) – which combines the antibody component of Roche’s HER2 cancer drug Herceptin with a chemotherapy payload – was approved by the FDA last month for heavily pre-treated breast cancer patients in record time.

The new trial also met the main endpoint of improving the objective response rate compared to chemo with either paclitaxel or irinotecan in the study subjects, who had progressed on two prior treatment regimens including a fluoropyrimidine drug, platinum therapy and Herceptin.

The new results add to the positive newsflow with the drug and will be welcome for AZ, which paid out a whopping $1.35bn upfront to license the drug last year in a deal that could eventually be worth up to $6.9bn if development and sales milestones are met.

The two companies are splitting development and marketing costs for Enhertu as well as global profits, except in Japan where Daiichi Sankyo is keeping exclusive rights.

AZ’s head of oncology José Baselga said that gastric cancer is typically diagnosed when it is at an advanced stage and has a high mortality rate, which makes the need for new therapies “especially urgent.”

“Given the previous results seen in our HER2 positive development programme and now in HER2 positive gastric cancer, we believe this antibody drug conjugate has the potential to redefine the treatment of patients with HER2 expressing cancers,” he added.

Analysts have suggested peak sales of Enhertu could go higher than $4bn a year, assuming that AZ and Daiichi Sankyo are able to roll out the drug as an earlier-line therapy for HER2-expressing cancers like breast and gastric cancer, as well as in low HER2-expressing tumours that could dramatically expand the potential market for the drug.

Article by
Phil Taylor

27th January 2020

From: Research



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