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Pembrolizumab provided long-term overall survival benefit in second-line treatment and can be effectively used for retreatment after disease progression.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
Among the firms presenting, drugmakers, speciality biotechs, and genetic testing firms provided an update on their precision oncology development programs.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
In two trials in the neoadjuvant setting reported at SABCS, one showed improved rates of pathologic complete response with added immunotherapy, and the other showed no difference.
Olaparib is the first PARP inhibitor approved in China for first-line maintenance treatment of germline and somatic BRCA mutated gynecological cancers.
The company is using the test to direct patient enrollment and treatment stratification in a trial of pembrolizumab (Keytruda) combination treatments.
This is the first anti-PD-1 drug approved for front-line treatment of advanced and unresectable, recurrent head and neck cancer in the EU.
Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.