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biocqr

09/11/17 12:28 PM

#213559 RE: poorgradstudent #213558

GTHX > The claim is Trilaciclib protects HSPC's which eliminates chemo related neutropenia and lymphopenia resulting in fewer transfusions, dose delays & reductions etc.

From their presentation...

Compelling open-label data: no febrile neutropenia (FN) in 51 patients,
>250 cycles chemo
(historical FN rates ~ 30% with topotecan)



From this poster...

• In this ongoing study, the combination of trilaciclib with topotecan is well tolerated, without any episodes of febrile
neutropenia or treatment-related SAEs

• The most common adverse events were hematologic toxicities attributed to chemotherapy; in the setting of frequent
hematologic monitoring, Grade 3/4 events recovered quickly, were associated with fewer topotecan dose
delays/reductions and less growth factor usage and transfusions than those reported in the literature
A pharmacologic drug-drug interaction resulting in reduced topotecan clearance and consequent increase in
topotecan exposure was identified; however, exposures at a topotecan dose of 0.75 mg/m2 with trilaciclib were
comparable to those reported in the literature for 1.5 mg/m2 topotecan alone

• Early anti-tumor results (ORR and CBR) are encouraging
• This novel approach, allowing the administration of chemotherapy with preservation of HSC and immune system
function, could potentially improve treatment outcomes for patients with CDK4/6-independent tumors

mcbio

01/12/18 10:08 PM

#216592 RE: poorgradstudent #213558

GTHX -

GTHX:

Been watching it for a while. Looked into it a while ago and decided I wasn't too impressed. But now we see what that opinion is worth!

On a fundamental basis, I'm really not sure why it's ramping up. The data aren't all that clear for its lead product.

Speaking of CDK4/6 more generally, did you see this on the potential for CDK4/6 inhibitors in enzalutamide-resistant and abiraterone-resistant CRPC: http://ascopubs.org/doi/full/10.1200/PO.17.00140 ? Any thoughts on the potential of CDK4/6 inhibitors here?

Also, will what EPIX is trying to do here in targeting the N-terminal domain potentially work on this front as well?