AstraZeneca and Merck's LYNPARZA Receives Approval in Japan for Treating Three Types of Advanced Cancer

Strategic Insights -

The Japanese Ministry of Health, Labor, and Welfare has granted concurrent approvals for the treatment of advanced ovarian, prostate, and pancreatic cancer with the use of LYNPARZA, a targeted therapy. The approvals are based on the results from the PAOLA-1, PROfound, and POLO Phase 3 trials, which demonstrated substantial progression-free survival and overall survival improvements in patients with biomarker-positive advanced ovarian, prostate, and pancreatic cancer, respectively. This development marks a significant milestone in the treatment of these aggressive types of cancer, offering patients in Japan a personalized treatment option tailored to their specific biomarkers.

Key Takeaways:

  • LYNPARZA is the first PARP inhibitor approved in Japan for the treatment of BRCA gene-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC) and metastatic pancreatic cancer.
  • The approval is based on results from the PAOLA-1, PROfound, and POLO Phase 3 trials, which showed significant improvements in progression-free survival and overall survival for patients with HRD-positive advanced ovarian cancer, BRCAm mCRPC, and HRBR-am metastatic pancreatic cancer, respectively.
  • LYNPARZA has been approved for use as maintenance treatment after first-line chemotherapy containing bevacizumab in patients with HRD-positive advanced ovarian cancer and as maintenance treatment after platinum-based chemotherapy for patients with BRCAm curatively unresectable pancreas cancer.
  • Prostate cancer is the third most common type of cancer in Japan, with over 100,000 new cases diagnosed in 2020.
  • Pancreatic cancer has one of the lowest survival rates of the most common cancers, with 44,000 new cases diagnosed in Japan in 2020.

Statistics:

  • PaOLA-1 trial results showed that LYNPARZA in combination with bevacizumab maintenance treatment demonstrated a substantial progression-free survival improvement (11.3 months) versus bevacizumab alone (6.7 months) for patients with HRD-positive advanced ovarian cancer.
  • In 2020, approximately 11,000 women in Japan were diagnosed with ovarian cancer, with more than 5,000 women dying of the disease.
  • PROfound trial results showed that LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations.
  • Over 100,000 new cases of prostate cancer were diagnosed in Japan in 2020.
  • LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo in patients with gBRCAm metastatic pancreatic cancer.

Sources:

  • The New England Journal of Medicine (for results from the PAOLA-1, PROfound, and POLO Phase 3 trials)
  • AstraZeneca press release (2021) announcing the approval of LYNPARZA in Japan for the treatment of advanced ovarian, prostate, and pancreatic cancer