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ESMO conference: AstraZeneca, GSK's ovarian cancer drugs show jump in survival

The U.K.'s two biggest drugmakers, AstraZeneca PLC and GlaxoSmithKline PLC, both reported highly anticipated data showing that targeted treatment with PARP inhibitor drugs significantly extended survival in women with ovarian cancer without the disease progressing.

The results open up the possibility of new treatment options for the fifth most common cancer in the world.

Over 28,000 cancer specialists from 138 countries gathered in Barcelona at the ESMO 2019 Congress, where the presentation of AstraZeneca's Paola-1 study of Lynparza taken in combination with Roche Holding AG's Avastin was shown to cut the risk of disease progression or death by 41% in ovarian cancer patients with and without the genetic BRCA mutation. The announcement was followed by results of GSK's Prima study of Zejula as maintenance treatment in women with newly diagnosed ovarian cancer that showed a 38% drop in disease progression or death compared with placebo.

AstraZeneca's Paola-1 trial of 806 patients with stage 3 or 4 ovarian cancer who had a partial or complete response to standard platinum-based chemotherapy and Avastin, reported progression-free survival of 22.1 months in the Lynparza group compared with 16.6 months in the placebo group.

Also known as olaparib, Lynparza has proven especially effective in patients that have a specific mutation called BRCA1/2 in headline results, but in this study it was effective in those without BRCA mutations as well. GSK's Zejula, or niraparib, showed benefit in all women with newly diagnosed ovarian cancer.

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PARP inhibitors, which block the enzyme known as poly-ADP ribose polymerase, are targeted therapies that kill cancer cells by hindering the protein that allows cancer cells to repair their DNA. The Paola and Prima results were announced at a presidential symposium at ESMO, and the latter was published simultaneously in The New England Journal of Medicine.

"[The Paola-1] study reports the greatest hazard ratio (0.59) and longest progression-free survival we have ever seen," said Isabelle Ray Coquard, professor at France's Centre Leon Bérard, Université Claude Bernard in Lyon. "Patient selection was not restricted by surgical outcome or BRCA mutation status, so participants represent the general population of women with advanced ovarian cancer," she told reporters at a press conference.

Progression-free survival with Lynparza reached 37.2 months in patients with a BRCA mutation and in patients with HRD, another inherited mutation. "The results in HRD patients without a BRCA mutation identify, for the first time, a patient population with greater clinical benefit from olaparib [or Lynparza] when added to bevacizumab [or Avastin]," said study author Ray-Coquard.

Distinguishing factors in the GSK Prima trial include the fact that patients did not receive Avastin, were not stratified according to BRCA status, and were treated for almost three years, said Ana Oaknin, a doctor at the Vall d'Hebron Institute of Oncology in Barcelona.

"The good thing in the outcome of our trial is that in all sub-groups you see meaningful clinical improvement, therefore you actually don't have to test it becomes a physician's choice if they test or not," said Axel Hoos, GSK's head of oncology, in conversation with journalists on the sidelines of the ESMO congress.

Ovarian cancer patients are often diagnosed only when the disease has reached an advanced stage and despite responding well to first-line treatment, they usually relapse within two years of diagnosis. But longer progression-free survival after first-line therapy is the main goal as it improves the probability of response to a new line of chemotherapy, according to Oaknin. "The combination of Avastin and Lynparza as maintenance therapy should become a new standard of care for patients with advanced ovarian cancer," she said.

"I think PARP inhibitors have been under-used and under-appreciated," said GSK's Hoos. "We said that when we acquired Tesaro ⁠— that was one of our reasons for acquiring the company ⁠— because we feel that this class of drugs can do a lot more than has been done with them so far."

"It's been a great year," Dave Fredrickson, AstraZeneca's head of oncology, said in an interview with S&P Global Market Intelligence. "When you look at the progress of the pipeline, it's showcased here," he said, referring to the ESMO 2019 congress, where the Cambridge, England-based company will unveil five late-breaking abstracts in total. "The pipeline's progressing and from a commercial perspective … in 2017 we had $4 billion in sales for the oncology business and for the first half of this year we had $4 billion in sales for the oncology business ⁠— so to be on a pace of doubling the size of the business in two years is a testimony also that it's not just the pipeline that's performing, commercially we're performing as well."

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.