AstraZeneca VP, Head of Medical Affairs, US Oncology, Discusses 10 Years of Lynparza Across Eight Indications

PE: Since LYNPARZA® (olaparib) was first approved in 2014, it has been expanded to eight indications across breast, prostate, pancreatic, and ovarian cancers. Can you discuss the unique aspects of the treatment that has made it the PARPi with the most FDA-approved indications?

Doti: LYNPARZA inaugurated this unique class of PARP inhibitors. This molecule was brought to market in that first indication by AstraZeneca 10 years ago on a mechanism of action that was probably disregarded, and it changed completely a lot of things for us. It was the first approval that we have in AstraZeneca and what we call the “new oncology”, although we have a legacy in oncology in breast cancer and prostate cancer that goes back 30 years ago in monotherapies like ZOLADEX and FASLODEX. We made a conscious decision to come back in oncology, and LYNPARZA was our first launch. That was the first thing for us, very important which is coming back into oncology in a different capacity.

Second thing is, we inaugurated two very relevant and important things with this class which is, the first approval was maintenance in ovarian cancer, so something that was never done before. Before that, in solid tumors, you would just go with chemotherapy, you get a response, and then you wait. And here we were able to prove that by adding LYNPARZA at the back end of that chemotherapy, you extend progression free survival and overall survival for these patients.

The third thing, which is very close to me because I didn’t mention this but I'm a hematologist by training, is that we inaugurated this new model of testing patients, not only for prognosis and treatment strategy for themselves, but actually to identify patients at risk within the family group. So, all of those challenges were the first for LYNPARZA. I think that was one of the reasons this has been such a successful brand.

It was established in a smaller indication but very relevant because of the unmet need. It brought benefit to patients first and second line and then in first line, but more relevantly, also benefit to patients that could have been impacted by those BRCA mutations in the future, and if they were not being identified that by that initial case. So, all incredible things. Beyond that, once we realize that it has potential in these specific sub-segments of patients that have homologous recombinant rearrangements that make them feasible to use LYNPARZA, we expanded our presence from first form variant cancer, as I mentioned before, and then went into the other places that BRCA has a role, which includes breast cancer with two indications there and prostate cancer, also two indications there and pancreatic cancer.

So all in all, I think it is the best part, because it was the first and because it has a unique safety profile. I think the proof of time, which is in these 10 years, and with all these indications serving more than 40,000 patients, we have seen that it works, it's safe, and it brings benefit to patients across tumor lines.