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ESMO 2019: Ovarian cancer is center stage as focus shifts to targeted therapies

Ovarian cancer is set to take center stage at the European Society of Medical Oncology meeting starting Sept. 27 in Barcelona as Europe's largest gathering of cancer specialists sift through the latest data pitting the U.K.'s two biggest drugmakers, AstraZeneca PLC and GlaxoSmithKline PLC, against each other in a highly competitive field of research.

The release of final results for their rival drugs, AstraZeneca's Lynparza and GSK's Zejula, could significantly change the way ovarian cancer is treated, according to analysts. Both experimental medicines belong to a class of drugs called PARP inhibitors, which are targeted therapies that kill cancer cells by blocking enzymes that let cancer cells repair their DNA. Also known as olaparib, Lynparza has proven especially effective in patients that have a specific genetic mutation called BRCA1/2 in headline results, while GSK's Zejula, or niraparib, has shown benefit in all women with newly diagnosed ovarian cancer, regardless of biomarker status.

Full results of the phase 3 Prima study of GSK's Zejula as maintenance treatment in women with newly diagnosed ovarian cancer are set to be unveiled at ESMO's presidential symposium, closely followed by progression-free survival phase 3 data in AstraZeneca's Paola-1 study of Lynparza taken alongside Roche Holding AG's Avastin, compared with just Avastin.

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"I think ESMO should be interesting because of that Paola versus Prima debate," said one analyst who spoke to S&P Global Market Intelligence on condition of anonymity. "To me that's the big, big debate in terms of share price relevant stuff, those are the big trials."

AstraZeneca's Greg Rossi said Paola 1 is designed around what is believed to be the most effective backbone therapy available in frontline ovarian cancer, the combination of chemotherapy with Avastin.

"We know that this is the most frequently used regimen pretty much across Europe (60-65%), Japan, the U.S. (50%) who are getting this," Rossi said in an interview with Market Intelligence. In that regimen you have around 10 months of Avastin after chemotherapy as a maintenance treatment; added to that are two years worth of Avastin in combination, followed by monotherapy for about 14 months, he said.

"We think that's the best way to get patients to stay in remission for as long as possible — that's the clinical goal," Rossi said. By contrast, GSK's Prima trial does not include Avastin, just chemotherapy.

In addition to the focus on ovarian cancer, investors are keen to see AstraZeneca's unveiling of the first phase 3 trial of a PARP inhibitor in prostate cancer that has spread. The trial results, dubbed Profound, are scheduled for Sept. 30. Oncology has long been a pillar of AstraZeneca's growth trajectory and forms the cornerstone of a pledge to drive sales beyond $45 billion by 2023.

"Full results of pivotal PARP studies anticipated at ESMO will be crucial in determining the commercial potential of AZ's Lynparza and GSK's Zejula," said Peter Welford, an analyst at Jefferies, in a preview note to clients. Furthermore, these trial results — along with AbbVie Inc.'s Velia study of veliparib combined with chemotherapy due to read out in the second half of 2019 — "could significantly change the way ovarian cancer patients are treated in the future," he said.

Barely a year ago, GSK's head of oncology, Axel Hoos, indicated that the Brentford, London-based pharmaceutical giant was interested in moving back into oncology — following its 2015 exit in an asset swap with Novartis AG — and had aggressive intentions well beyond its sole drug candidate, a fourth-line treatment for a type of skin cancer, which he forecast could attain annual sales of $5 billion.

The $5.1 billion acquisition of Tesaro Inc. and a subsequent deal with Germany's MERCK KGaA on lung cancer has resulted in a pipeline at GSK that currently has 17 assets in oncology alone. Following R&D head Hal Barron's review, some 11 research projects have been dropped, a number of which were in respiratory medicine, and GSK has moved toward immune-based research and oncology.

"Without Luke Miels, none of this stuff would be happening — and of course, he knows the PARP space backwards," said the unnamed analyst, referring to the head of GSK's global pharmaceutical business, who joined CEO Emma Walmsley two years ago from Cambridge-based AstraZeneca. Prior to that, Miels and Barron both worked at Roche and were involved in the development and launch of cancer treatment Avastin. "It's quite ironic because you're getting people at AZ who used to work at Genentech telling you one thing and people at GSK who used to work at Genentech saying something different to you."