AstraZeneca (AZ) has received recommendations for Imfinzi, Enhertu and Lynparza from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) for the treatment of biliary tract cancer, advanced gastric cancer and prostate cancer, respectively.
Imfinzi (durvalumab) has been recommended as a first-line treatment of adult patients with unresectable or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine plus cisplatin).
The CHMP’s decision was based on primary results from the phase 3 TOPAZ-1 trial in which an interim analysis showed Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone.
Updated results from the trial after an additional 6.5 months of follow-up showed a 24% reduction in the risk of death versus chemotherapy alone, with more than two times as many patients estimated to be alive at two years versus chemotherapy alone.
The CHMP also recommended Enhertu (trastuzumab deruxtecan), which is being jointly developed and commercialised with Daiichi Sankyo, as a monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
Results from the DESTINY-Gastric02 and the DESTINY-Gastric01 phase 2 trials were the driving force behind the positive opinion. In DESTINY-Gastric02, updated results showed treatment with Enhertu resulted in a confirmed objective response rate (ORR) of 41.8%. Median duration of response was 8.1 months and median overall survival (OS) was 12.1 months.
Meanwhile, in DESTINY-Gastric01, updated results showed treatment with Enhertu resulted in an ORR of 51.3% versus 14.3% with chemotherapy (irinotecan or paclitaxel). Patients treated with Enhertu also had a 40% reduction in the risk of death versus patients treated with chemotherapy, with a median OS of 12.5 months versus 8.9 months. Additionally, confirmed ORR was 42.0% with Enhertu versus 12.5% with chemotherapy.
The final recommendation was for AZ and MSD’s – known as Merck & Co in the US and Canada – Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer for whom chemotherapy is not clinically indicated.
The CHMP’s opinion was based on results from the PROpel phase 3 trial in which Lynparza in combination with abiraterone and prednisone or prednisolone reduced the risk of disease progression or death by 34% versus abiraterone alone.
Median radiographic progression-free survival (rPFS) was 24.8 months for Lynparza plus abiraterone versus 16.6 months for abiraterone alone, and results also showed that Lynparza in combination with abiraterone extended median rPFS by almost one year, with a median rPFS of 27.6 months versus 16.4 with abiraterone alone.