Tablet Form of Lynparza Approved in Japan as Maintenance Therapy for Recurrent Ovarian Cancer

Tablet Form of Lynparza Approved in Japan as Maintenance Therapy for Recurrent Ovarian Cancer

Japanese women with advanced ovarian cancer can now be treated with the new tablet formulation of Lynparza (olaparib) after a recent approval by the Japanese Ministry of Health, Labour and Welfare.

The treatment was approved to delay disease progression in women who responded to a previous platinum-based chemotherapy regimen, regardless of their BRCA mutation status.

Lynparza, jointly developed by AstraZeneca and Merck (known as MSD outside the U.S. and Canada), is taken twice daily in 300 mg tablets.

“We are proud to bring this important first-in-class treatment to women with platinum-sensitive relapsed ovarian cancer in Japan who currently have very few treatment options,” Dave Fredrickson, executive vice president, head of the oncology business unit at AstraZeneca, said in a press release.

“The trials show that with Lynparza maintenance therapy, women with ovarian cancer can live longer without their disease worsening, and Lynparza is well tolerated,” he added.

Lynparza belongs to a group of chemical compounds known as poly ADP-ribose polymerase (PARP) inhibitors. It is the first of its kind to be approved in Japan.

The drug acts by preventing cells from repairing their DNA errors. Because cancer divides at a faster pace, they accumulate errors faster than healthy cells, leading to cancer cell death. Lynparza is particularly effective in cancers with mutations in other DNA-repairing genes, such as BRCA1 and BRCA2.

The Japanese approval was supported by data from the SOLO-2 Phase 3 trial (NCT01874353) and the Phase 2 Study 19 trial (NCT00753545).

SOLO-2 enrolled 295 patients with ovarian, fallopian tube, and primary peritoneal cancer with inherited BRCA mutations. Patients randomly received 300 mg Lynparza tablets or placebo twice daily.

Study 19 enrolled 265 patients with relapsed, high-grade serous ovarian cancer, regardless of BRCA mutation status, who were randomized to receive 400 mg Lynparza tablets or placebo twice daily.

All women in both trials had relapsed or recurrent disease, but were in partial or complete response following their last platinum-based chemotherapy.

In both studies, Lynparza significantly reduced the risk of disease progression or death – by 70% in SOLO-2 and by 65% in Study 19.  The most common adverse effects were nausea, anemia, fatigue, and vomiting.

“Today’s decision is significant for Lynparza and, more importantly, for Japanese patients living with advanced ovarian cancer,” said Roy Baynes, senior vice president and head of global clinical development, MSD Research Laboratories.

“Our global collaboration with AstraZeneca reinforces how our joint efforts can advance science for patients, and we look forward to working together to explore the potential of Lynparza across multiple tumour types,” added Baynes, also chief medical officer at MSD Research Laboratories.

Lynparza was approved in the U.S. for the same indication in August 2017.

The treatment is also being reviewed by the Japanese regulatory agency for the treatment of patients with unresectable or recurrent BRCA-mutated, HER2-negative breast cancer. A final decision is expected in the second half of 2018.