Replies to post #213576 on Biotech Values

[biocqr]

GTHX >

it concerns me that poorgradstudent is skeptical

Same here...he's got me a little spooked :)

The P2a read out is 1Q 2108 so we'll know more then.

There were no cases of Febrile Neutropenia in the P1b (n=17) and no FN in the P1b (n=51) combo w/topocan for 1/2L SCLC so the primary endpoint of myelo-suppression/FN transfusions in the randomized P2a (n=77) looks encouraging.

Neutropenia (n=2) and thrombocytopenia (n=1) were reported in the P1b so that's something to keep an eye on.

In the P2a it would be surprising to see a significant difference favoring ORR in the placebo arm.

I plan on holding through the P2a read out...for better or worse.

P1b results...

Trilaciclib (G1T28): A cyclin dependent kinase 4/6 inhibitor, in combination with etoposide and carboplatin (EP) for extensive stage small cell lung cancer (ES-SCLC)—Phase 1b results.

http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.8568

Results: 19 pts were enrolled in the Phase 1b: 10 pts received T 200 mg/m2 + EP and 9 pts received T 240 mg/m2 + EP. T + EP was well tolerated. 2 pts at T 200 mg/m2 and 1 pt at T 240 mg/m2 experienced asymptomatic DLTs in cycle 1. 2 pts (1 at each dose) had an ANC < 1500 on cycle 2 day 1, delaying the start of cycle 2, and 1 pt at the T 200 mg/m2 dose had grade 4 thrombocytopenia. There were no cases of febrile neutropenia or bleeding. PK analysis showed no drug interactions between T and EP. 17/19 pts were evaluable: 1 pt had CR, 14 had PR (confirmed ORR = 88%); 1 pt had SD (clinical benefit rate = 94%). Conclusions: In the Phase 1b part of the study, T + EP was well tolerated. Early activity results are promising with a confirmed objective response rate of 88%. This novel approach allowing the administration of chemotherapy while preserving HSPC and immune system function could potentially improve treatment outcomes for SCLC pts. Clinical trial information: NCT02499770.