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ESMO conference: AstraZeneca's Lynparza slows disease in prostate cancer

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ESMO conference: AstraZeneca's Lynparza slows disease in prostate cancer

AstraZeneca PLC's cancer therapy Lynparza was once again the focus of attention after data from the Profound trial released at the ESMO congress showed that the treatment slowed disease progression in castration-resistant prostate cancer that has spread, and could improve survival.

Lynparza, or olaparib, belongs to a class of drugs known as PARP inhibitors, which are targeted therapies that kill cancer cells by blocking enzymes that let the cancer cells repair their DNA. Some 350,000 men die as a result of prostate cancer every year out of the more than 1.2 million men who are diagnosed with the disease worldwide. To date, treatment options have included surgery, radiotherapy, chemotherapy or hormonal treatment although these options are limited once the cancer has spread.

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In the Profound study, Lynparza was compared with two new hormonal agents Astellas Pharma Inc.'s Xtandi, also known as enzalutamide, and Janssen's Zytiga, or abiraterone in two different groups; one, composed of men with the BRCA1/2 and ATM genetic mutations, while the second had a broader range of less well studied faulty DNA repair genes. Results showed a statistically significant and clinically meaningful improvement, with Lynparza improving progression-free survival for men with BRCA1/2 or ATM-mutated prostate cancer for 7.4 months, compared with 3.6 months for those on abiraterone or enzalutamide. Lynparza cut the risk of disease progression or death by 66%.

"We saw the benefits of [Lynparza] in all sub-groups of patients, regardless of country, age, prior therapy and severity of disease, including in those with worse disease that had spread to their liver or lungs," said Maha Hussain, professor at Chicago's Robert H. Lurie Comprehensive Cancer Center at Northwestern University. "To see such a significant effect on disease progression and other clinically relevant effects such as pain progression and objective response rate is a remarkable achievement in such heavily pre-treated patients with prostate cancer," she said at the press conference.

PARP inhibitors have shown efficacy in breast and ovarian cancers, with Lynparza seen to be especially effective in women with the BRCA1/2 genetic mutation. But results presented at the ESMO 2019 conference have also demonstrated Lynparza's effectiveness in a wider population beyond BRCA. As a result of the Profound study, Scot Ebbinghaus, vice president of clinical research at Kenilworth, N.J.-based Merck & Co. Inc. which co-develops Lynparza believes that men with prostate cancer may start to have genetic testing to help guide therapy.

"Beyond BRCA, that's been a recurring theme of this meeting," said Ebbinghaus in an interview with S&P Global Market Intelligence. "What we're seeing in Profound, in [AstraZeneca's Paola study for ovarian cancer], we're seeing the benefits of olaparib extend beyond the BRCA population. I think the data here would show that it would be beneficial to have a test for BRCA1 or 2 but also this panel of genes."

Dave Fredrickson, head of oncology at AstraZeneca, said there is some way to go to establish testing for this additional panel of genes in the Profound trial, which together with BRCA1/2 account for 25% of the population.

"There's a lot of work that needs to continue to happen on this," he said in an interview with S&P Global Market Intelligence. "But again, I think that once you have a treatment that shows that testing is important, then we start to see that testing quality increases and that testing uptake increases: we saw it with HER2, we saw it with EGFR, we saw it with BRCA and we're going to see it with HRRM and that's the path it needs to go down."

The Profound data is the first time that molecular targets have been identified that allow a precision medicine approach to the treatment of prostate cancer, Fredrickson said. "It's really been a one-size-fits-all approach to how we treat these patients," he said.

Lynparza has been approved for use in advanced ovarian cancer and breast cancer that has spread. AstraZeneca agreed to an $8.5 billion collaboration deal with Merck & Co. in 2017 to co-develop Lynparza with the U.S. pharma group, and the PARP inhibitor is in a broad range of ongoing clinical trials, as a monotherapy and in combination with other drugs.

"It's been a very fruitful collaboration," Ebbinghaus said of the Lynparza alliance. "AstraZeneca has been in the DNA damage repair area for a very long time, they have a lot of expertise — sometimes though, it's nice to have a fresh set of eyes to take a look at the data."

"It's like a marriage," he said. "There's always some back and forth."

The European Society for Medical Oncology is holding its 2019 scientific meeting in Barcelona, where more than 3,900 study abstracts have been submitted for review by oncology professionals from around the world.