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AZ and Daiichi get speedy review for rival to Roche’s HER2 drugs

Could add to AZ's portfolio of emerging cancer drugs


AstraZeneca and Daiichi have picked up a priority review from the FDA for their breast cancer therapy trastuzumab deruxtecan, setting up an approval in the second quarter of 2020.

The HER2-targeting antibody-drug conjugate (ADC) – also known as DS-8201 – will be reviewed by the US regulator on the strength of the phase 2 DESTINY-Breast01 trial. That showed a “clinically meaningful” 60% response rate in patients who had failed treatment with Roche’s anti-HER2 ADC Kadcyla (trastuzumab emtansine), its nearest rival.

Like Kadcyla, DS-8201 combines the HER2-targeting of trastuzumab with a cell-killing chemotherapy component designed to improve its ability to kill breast cancer cells. DS-8201 is said to be a more potent ADC than Roche’s drug because it carries a topoisomerase inhibitor rather than Kadcyla’s tubulin inhibitor – and that means it can carry a greater cytotoxic payload.

Although it has crossed the blockbuster threshold this year, Kadcyla is still the runt of Roche’s HER2 litter lagging well behind Herceptin (trastuzumab) and Perjeta (pertuzumab) in sales terms. It made just over $1bn in the first nine months of this year from its use in patients who relapse after or don’t respond to Herceptin.

Kadcyla had been tipped to become a multibillion dollar product if it could move into first-line use in HER2-positive breast cancer, but it failed to improve on Herceptin in those settings in trials.

If approved, DS-8201 would also be used well down the treatment pathway, but AZ and Daiichi’s ambitions for the drug go much further, with additional trials on the go in order to move it into earlier lines of treatment so as to challenge Roche’s Herceptin/Perjeta duo.

The two partners have another strategy too, which is to try to position DS-8201 for the treatment of breast cancer patients whose tumours express lower levels of the HER2 biomarker than would ordinarily warrant HER2 therapies.

If successful, that would dramatically increase the eligible patient population in breast cancer and potentially also unlock use of the drug in other tumours, including gastric, colorectal, and non-small cell lung cancer (NSCLC).

AZ must be confident of that strategy as it paid a whopping $1.35bn upfront to license DS-8201 in May, with the ceiling value of the deal as high as $6.9bn if development and sales milestones are met.

Analysts’ expectations for sales potential vary, depending on how effectively AZ and Daiichi extend its use, but cluster around the $2bn mark in 2024 assuming a launch next year.

DS-8201 ADC would add to AZ’s portfolio of emerging cancer drugs, sitting alongside cancer immunotherapy Imfinzi (durvalumab), targeted therapy Tagrisso for lung cancer and PARP inhibitor Lynparza (olaparib) for ovarian and breast cancer which collectively brought in more than $3bn in revenues last year.

Article by
Phil Taylor

18th October 2019

From: Regulatory



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