Keytruda begins pursuit of rivals in small cell lung cancer
Set for competition with Opdivo
Merck & Co. has gained approval for Keytruda for use in third line treatment of small cell lung cancer (SCLC).
Unusually for the runaway leader in the PD-1/PD-L1 immunotherapy field, Keytruda is playing catch up with its rivals in this tumour type, where BMS’ Opdivo is already approved as a third line therapy in SCLC, with Roche’s Tecentriq gaining a prized first line indication in March.
Analysts forecast this lead could help Roche generate $1.5bn in sales from the indication - but one that Merck has its eyes on.
Keytruda can now be used as a monotherapy for small-cell lung cancer patients (SCLC) who have progressed after platinum-based chemotherapy or other prior lines of treatment.
The drug’s approval was fast-tracked by the FDA following the results of its KEYNOTE-158 and KEYNOTE-028 trials. These trials showed that when Keytruda was given as monotherapy to SCLC patients whose cancer had progressed despite prior therapies, they had an objective response rate (ORR) of 19%.
Bearing in mind the normal caveats about comparing such studies, Keytruda’s KEYNOTE-158 and -028 trials suggest a small but significant advantage over Opdivo in overall response rate.
Merck is already exploring Keytruda’s use in combination with chemotherapy in a phase 3 KEYNOTE-604 study. This study focuses on recently-diagnosed patients with advanced-stage SCLC, which would put it in more direct competition with Tecentriq.
EvaluatePharma forecasts that Keytruda will be the top selling drug worldwide in 2024, with predicted sales of 17bn, its lead in non-small cell lung cancer (NSCLC) being the primary driver of this expected success.
Keytruda has also recently been filed as a first-line treatment for head and neck cancer, for use as a monotherapy and in combination with chemotherapy.
默克公司。已获得 Keytruda 用于小细胞肺癌 (SCLC) 三线治疗的批准。不同寻常的是，对于 PD-1/PD-L1 免疫疗法领域失控的领跑者，Keytruda 在这一肿瘤类型上正在迎头赶上竞争对手，BMS 的 Opdivo 已经获批作为 SCLC 的三线疗法，罗氏的 Tecentriq 在 3 月份获得了珍贵的一线适应症。分析师预测，这一领先优势可能会帮助罗氏在这一适应症上创造 15 亿美元的销售额——但也是默沙东关注的一个。Keytruda 现在可以作为一种单药疗法，用于铂类药物化疗或其他既往治疗线后进展的小细胞肺癌患者 (SCLC)。FDA 在 KEYNOTE-158 和 KEYNOTE-028 试验结果后，对该药的批准进行了快速通道。这些试验表明，当 Keytruda 作为单药疗法给予尽管接受过既往治疗但癌症仍然进展的 SCLC 患者时，他们的客观缓解率 (ORR) 为 19%。考虑到比较这类研究的正常注意事项，Keytruda 的 KEYNOTE-158 和-028 试验表明，与 Opdivo 相比，在总缓解率方面有微小但显著的优势。默沙东已经在一项 3 期 KEYNOTE-604 研究中探索 Keytruda 与化疗联合使用。这项研究主要针对近期确诊的晚期 SCLC 患者，这将使其与 Tecentriq 处于更直接的竞争中。EvaluatePharma 预测，Keytruda 将是 2024 年全球销量第一的药物，预测销售额为 170 亿，其在非小细胞肺癌 (NSCLC) 领域的领先地位是这一预期成功的主要驱动力。Keytruda 最近也被申报为头颈癌的一线治疗药物，用于单药治疗和与化疗联合治疗
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