Results

AstraZeneca throws down the gauntlet with a PhIII victory in head-to-head PARP war with Tesaro

Sean Bohen, AstraZeneca

AstraZeneca has posted another success in its campaign to expand the use of its PARP inhibitor Lynparza (olaparib).

In what has become a head-to-head showdown with Tesaro, which has a rival PARP under review at the FDA, AstraZeneca today heralded a top-line success for Lynparza in a Phase III study of HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations.

Like Tesaro, AstraZeneca’s pivotal study focused on a comparison with physician’s choice of chemotherapies, with Lynparza coming out ahead on progression-free survival.

Lynparza got an early start in the market, thanks to FDA reviewers who were willing to look past the relatively weak data that AstraZeneca $AZN had posted for this drug. Richard Pazdur’s team was anxious to get a PARP into the market for ovarian cancer, where Tesaro is lining up its first shot on their franchise drug. A few backers on the sell side have projected billions in peak sales for Tesaro’s drug, but they’ll have to get around AstraZeneca to get it.

As we reported a few days ago, niraparib sits high on a list of 15 potential blockbusters ready to hit the market this year, with 2022 sales revenue projected at $1.8 billion for the ovarian cancer market. And that has kept the focus on ongoing buzz about a potential buyout for Tesaro.

Analysts will have to wait for the actual data, though, on an indication that they say could be worth a blockbuster billion dollars in annual revenue for Tesaro. Seamus Fernandez called it a clear win for the pharma giant:

This is the first Phase 3 readout for a PARP inhibitor in breast cancer and will likely have positive read-through for similarly designed trials of PFE’s (MP) talazoparib (EMBRACA trial; data expected in 1H:17) and TSRO’s (MP) niraparib (BRAVO trial; data expected in 2H:17). Importantly, this represents a win for AZN, which is building its DNA Damage Response (DDR) portfolio around Lynparza, as well as providing the first validation for the PARP inhibitor class outside of ovarian cancer. We continue to view AZN as our top pick with a number of high-impact catalysts on the horizon. Reiterate OP.

Shares of AstraZeneca jumped 1.7% on the news.

The success is a key win for AstraZeneca, which has been working hard to follow up on Lynparza’s approval with solid evidence of its broader potential. The drug has proven to be one of the few big bright spots for the pharma giant as it awaits combo data on the checkpoint inhibitor durvalumab and tremelimumab.

These aren’t the only two PARPs in the pipeline. Pfizer acquired talazoparib in its $14 billion buyout of Medivation while Clovis achieved an approval for Rubraca last December.

AstraZeneca CMO Sean Bohen said:

These results are positive news for patients with BRCA-mutated metastatic breast cancer, a disease with a high unmet need, and are the first positive Phase III data for a PARP inhibitor beyond ovarian cancer. This is highly encouraging for the development of our broad portfolio which aims to treat multiple cancers by targeting DNA damage response pathways.


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RAPS Regulatory Convergence 2017