FDA’s approval for Keytruda/chemo combo as first-line therapy

작년 NSCLC 에서 first-line therapy 로 FDA 승인을 받은 후 PD-(L)1 checkpoint 의 패권을 가져간 머크가 이번에는 chemo combo 로 다시 한 번 NSCLC 의 표준 치료법을 제시했다.

Pembro + CP significantly improved ORR (55% vs 29%; P = 0.0016) and PFS (HR 0.53, 95% CI 0.31-0.91, P = 0.0102; median 13.0 vs 8.9 mo). Overall survival was similar; 6-mo survival rates were 92% in each arm.

출처 링크 (ESMO 2016 Press Release)

작년 pembrolizumab 단독으로 1L 승인을 받았을 때의 데이터를 보면,

Median progression-free survival was 10.3 months (95% confidence interval [CI], 6.7 to not reached) in the pembrolizumab group versus 6.0 months (95% CI, 4.2 to 6.2) in the chemotherapy group (hazard ratio for disease progression or death, 0.50; 95% CI, 0.37 to 0.68; P<0.001). … (중략) … The response rate was higher in the pembrolizumab group than in the chemotherapy group (44.8% vs. 27.8%)

출처 링크 (N Engl J Med 2016; 375:1823-1833)

RR, PFS 모두 pembrolizumab 단독보다 뛰어나고, chemo 단독에 비해서는 월등히 뛰어난 결과를 보였다.

기사

Arginase inhibitor CB-1158

Originator: Calithera Biosciences

Buyer: Incyte

Upfront payment: $45m

Estimated value: ~$500m

Target molecule: Arginase

Target cell: MDSC

Clinical setting: Combination with anti-PD-1 ab

Current stage: P1

Another Arginase inhibitors:

Target evaluation: fast-follow 가능?

http://www.calithera.com/wp-content/uploads/2016/01/Keystone-immunotherapy-2016-poster.final_.pdf

https://globenewswire.com/news-release/2017/01/30/911912/0/en/Incyte-and-Calithera-Biosciences-Announce-Global-Collaboration-to-Develop-and-Commercialize-CB-1158-a-First-in-class-Small-Molecule-Arginase-Inhibitor.html