Bristol-Myers Squibb has secured FDA approval for Augtyro, a lung cancer therapy it acquired as part of its $4.1 billion takeover of Turning Point Therapeutics last year that it hopes will challenge rival drugs from Roche and Pfizer.

百时美施贵宝已获得FDA对Augtyro的批准，Augtyro是其去年收购的41亿美元转折点疗法的一部分，希望能够挑战罗氏和辉瑞的竞争对手药物。

Augtyro (repotrectinib), a tyrosine kinase inhibitor (TKI) targeting ROS1 and NTRK, has been cleared for patients with ROS1-positive non-small-cell lung cancer (NSCLC) on the back of overall response rate (ORR) data from the phase 1/2 TRIDENT-1 study after a priority review by the US regulator.

Augtyro（repotrectinib）是一种靶向ROS1和NTRK的酪氨酸激酶抑制剂（TKI），已被ROS1阳性非小细胞肺癌（NSCLC）患者清除，其总体反应率（ORR）数据来自美国监管机构优先审查后的1/2期TRIDENT-1研究。

Importantly, the drug has been given a ‘line-agnostic’ label, meaning it can be used in both treatment-naïve and previously treated patients, which is seen as crucial to unlocking its sales potential.

重要的是，该药物已被赋予“与线无关”的标签，这意味着它可用于未接受过治疗的患者和之前接受过治疗的患者，这被视为释放其销售潜力的关键。

In ROS1-positive NSCLC patients, the drug achieved a 79% ORR in patients who had never previously been treated with a ROS1-targeting TKI, made up of 6% complete responses and 73% partial responses, with a median duration of response of 34.1 months.

在ROS1阳性的NSCLC患者中，该药物在以前从未接受过ROS1靶向TKI治疗的患者中达到79%的ORR，由6%的完全缓解和73%的部分缓解组成，中位缓解时间为34.1个月。

A second cohort of patients who had been treated with one prior ROS1 TKI such as Roche’s already-approved Rozlytrek (entrectinib) and Pfizer’s Xalkori (crizotinib) and no prior chemotherapy saw an ORR of 38% and with a median duration of 14.8 months.

第二组接受过ROS1 TKI治疗的患者，如罗氏已经批准使用Rozlytrek（entrectinib）和辉瑞的Xalkori（crizotinib），之前没有接受过化疗，ORR为38%，中位持续时间为14.8个月。

BMS also looked at patients whose cancer had already spread to the central nervous system (CNS) at enrolment, with responses seen in seven out of eight TKI-naïve patients and five of 12 of those who were TKI-pretreated.

BMS还研究了入选时癌症已经扩散到中枢神经系统（CNS）的患者，其中8例TKI初治患者中有7例出现反应，12例TKI预处理患者中有5例出现反应。

“New treatment options continue to be needed for patients with ROS1 fusion-positive NSCLC that support important clinical goals, including achieving durable therapeutic responses,” said Jessica Lin of Massachusetts General Hospital and Harvard Medical School, TRIDENT-1’s primary investigator

马萨诸塞州总医院和哈佛医学院的Jessica Lin说：“对于ROS1融合阳性的非小细胞肺癌患者，仍然需要新的治疗方案来支持重要的临床目标，包括实现持久的治疗反应。”

“Based on the data we have seen in the TRIDENT-1 trial, repotrectinib has the potential to become a new standard of care option for patients with locally advanced or metastatic ROS1 fusion-positive lung cancer,” she added.

她补充说：“根据我们在TRIDENT-1试验中看到的数据，repotrectinib有可能成为局部晚期或转移性ROS1融合阳性肺癌患者的新标准治疗选择。”。

Augtyro will be launched onto the US market in mid-December and will become an option for around 1% to 2% of patients with NSCLC, according to BMS. Analysts at SVB Securities have previously suggested it could become a blockbuster if eventually approved across multiple ROS1-positive tumour types.

据BMS称，Augtyro将于12月中旬投放美国市场，并将成为约1%至2%NSCLC患者的选择。SVB证券的分析师之前曾表示，如果最终批准多种ROS1阳性肿瘤类型，它可能会成为重磅炸弹。

So far, however, the available drugs to treat ROS1-mutated NSCLC haven’t really gathered much momentum. Rozlytrek was approved by the FDA in 2019 but is still making modest sales at around $70 million in the first nine months of this year, which includes revenue from a second indication in NTRK gene fusion-positive solid tumours..

然而，到目前为止，用于治疗ROS1突变的NSCLC的可用药物尚未真正获得太多动力。Rozlytrek于2019年获得FDA批准，但今年前9个月仍以约7000万美元的销售额进行适度销售，其中包括NTRK基因融合阳性实体瘤的第二项适应症。。

ALK inhibitor Xalkori meanwhile has been approved to treat ROS1-positive NSCLC since 2016 and made $283 million in the same period, split between that indication and ALK-mutated NSCLC and lymphoma.

ALK抑制剂Xalkori自2016年以来已被批准用于治疗ROS1阳性的NSCLC，同期收入2.83亿美元，分为该适应症和ALK突变的NSCLC和淋巴瘤。

BMS said Augtyro is a “next-generation” TKI for ROS1 cancers that can reduce the risk of some forms of treatment resistance, a perennial problem with targeted cancer therapies. It is also being teased in NTRK-positive tumours.

BMS表示Augtyro是ROS1癌症的“下一代”TKI，可以降低某些形式的治疗抵抗的风险，这是靶向癌症治疗的长期问题。它也在NTRK阳性肿瘤中被戏弄。