- AstraZeneca and Merck & Co. on Thursday said a combination of their cancer drug Lynparza and an experimental drug called cediranib failed to keep relapsed ovarian cancer patients' disease in check better than standard chemotherapy.
- Lynparza is now approved as maintenance therapy for some patients in remission following chemo, and success in this study would have meant a chance to expand into relapsed disease.
- AstraZeneca and Merck's strategy of expanding Lynparza's market has been mostly successful to date, most recently with the Food and Drug Administration adding some pancreatic cancers to the array of conditions it's approved to treat.
The miss in combination with cediranib is all the more surprising given the companies' recent success in combining Lynparza with another drug from the same class, Roche's Avastin.
Both cediranib and Avastin work by blocking the growth of blood vessels feeding tumors, and the case for a Lynparza-Avastin pairing was shown in the PAOLA-1 trial of patients who have already responded to first-line treatment.
Success with cediranib would have given AstraZeneca the strategic advantage of a wholly owned combination therapy, as Lynparza is co-owned with Merck. Cediranib hasn't been approved in any indication.
This trial, called GY004, was sponsored by the National Cancer Institute and the non-profit research consortium NRG Oncology. It tested ovarian cancer patients who have received platinum-based chemotherapy and other types of treatment, can still respond to chemo and have experienced a recurrence of disease following complete elimination of their tumors.
Measured by progression-free survival, or the length of time patients live without their tumors getting larger or spreading, the Lynparza-cediranib combination did no better than platinum-based chemotherapy.
Lynparza is from a newer class of treatments called PARP inhibitors. Trial results have shown that it can delay disease progression and death most often in patients whose tumors express a mutation in a gene called BRCA. In this trial, only some patients had to be BRCA positive, a factor that could have contributed to the trial's failure.
The Lynparza-cediranib combination still has some opportunities for success. AstraZeneca is sponsoring the CONCERTO trial in patients who have relapsed quickly after platinum-based chemotherapy. NCI is testing the drugs together in a similar setting in another study, and University College London has a trial going in the maintenance treatment setting.
AstraZeneca recorded $1.2 billion in sales for Lynparza in 2019, making it the third-biggest oncology drug for the British drugmaker.