New data strengthen data for Lynparza in prostate cancer
AstraZeneca and Merck & Co’s drug boosted survival in late-stage trial
AstraZeneca and Merck & Co’s PARP inhibitor Lynparza has boosted survival in a late-stage trial involving men with prostate cancer, bolstering the data for the drug as it goes through regulatory review for the new indication.
The new results from the PROfound study show that Lynparza (olaparib) improved overall survival (OS) compared to hormonal therapies in men with advanced castration-resistant prostate cancer (CRPC) with BRCA1/2 or ATM mutations.
Last year, AZ and Merck reported that Lynparza was able to extend the time to radiographic disease progression or death in these patients, setting up regulatory filings for the drug as a second-line therapy for CRPC in patients with homologous recombination repair gene mutations (which include BRCA1/2 and ATM) earlier this year.
If approved, prostate cancer would become the fourth indication for the PARP inhibitor after ovarian, breast and most recently pancreatic cancer, unlocking a major new market for a drug that is already a blockbuster, with AZ reporting sales of $1.2bn last year.
Prostate cancer is the most common cancer in men, the second most prevalent overall after breast cancer, and its incidence is on the rise due to the ageing global population. An estimated 1.3 million new cases were diagnosed worldwide in 2018.
For CRPC patients, whose cancer continues to grow despite standard anti-androgen therapies, a green light for Lynparza would provide an alternative to chemotherapy or radiotherapy as second-line options.
The new generation of cancer immunotherapies like PD-1/PD-L1 inhibitors have also disappointed when given as monotherapies for CRPC, although there has been some encouraging data with combination regimens including Merck’s Keytruda (pembrolizumab) with Lynparza.
Lynparza was filed for CRPC with the FDA in January, shortly after Clovis Oncology’s rival PARP inhibitor Rubraca (rucaparib).
Both drugs have been granted an accelerated six-month review by the US regulator, but AZ’s drug is going after a slightly wider patient population, as Rubraca is filed for BRCA-1/2-positive tumours only.
“Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve,” said José Baselga, AZ’s head of oncology R&D,.
“We are thrilled by these results for Lynparza and we are working with regulatory authorities to bring this medicine to patients as soon as possible,” he added.
Meanwhile AZ and MSD have aspiration to extend the use of Lynparza into first-line treatment of metastatic CRPC, and are conducting a phase 3 trial of the drug in combination with Johnson & Johnson’s Zytiga (abiraterone acetate) in this patient group, with results due next year.
AstraZeneca 和 Merck&Co 的 PARP 抑制剂 Lynparza 在前列腺癌男性患者中开展的一项晚期试验中提高了患者的生存率，支持了该药物在新适应症监管审查中的数据。provest 研究的新结果显示，与激素疗法相比，Lynparza (olaparib) 改善了携带 BRCA1/2 或 ATM 突变的晚期去势抵抗性前列腺癌 (CRPC) 男性患者的总生存期 (OS)。去年，AZ 和默沙东报告称，Lynparza 能够延长这些患者放射学疾病进展或死亡的时间，今年早些时候为该药设立了监管备案，作为携带同源重组修复基因突变（其中包括 BRCA1/2 和 ATM）的 CRPC 患者的二线疗法。如果获批，前列腺癌将成为继卵巢癌、乳腺癌和最近的胰腺癌之后 PARP 抑制剂的第四个适应症，为一个已经是重磅炸弹的药物打开了一个主要的新市场，AZ 去年报告的销售额为 12 亿美元。前列腺癌前列腺癌是男性最常见的癌症，是仅次于乳腺癌的总体发病率第二高的癌症，由于全球人口老龄化，其发病率呈上升趋势。2018 年全球估计有 130 万新发病例。对于 CRPC 患者，尽管接受了标准的抗雄激素治疗，其癌症仍继续生长，Lynparza 的绿灯将为化疗或放疗提供二线选择。像 PD-1/PD-L1 抑制剂这样的新一代肿瘤免疫疗法在作为 CRPC 的单药治疗时也让人失望，尽管已经有一些令人鼓舞的联合治疗方案的数据，包括默沙东的 Keytruda (pembrolizumab) 与 Lynparza。在 Clovis Oncology 的竞争对手 PARP 抑制剂 Rubraca (rucaparib) 上市后不久，Lynparza 于 1 月份向 FDA 提交了 CRPC 申请。这两种药物都已经获得了美国监管机构为期 6 个月的加速审查许可，但 AZ 的药物正在追求更广泛的患者人群，因为 Rubraca 仅用于 BRCA-1/2 阳性肿瘤。AZ 肿瘤研发部负责人 Jose
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