FORWARD II ASCO Abstract | IMGN Message Board Posts

ImmunoGen, Inc.

  IMGN website

IMGN   /  Message Board  /  Read Message

 

 






Keyword
Subject
Between
and
Rec'd By
Authored By
Minimum Recs
  
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board
Msg  49453 of 49773  at  5/15/2019 5:22:17 PM  by

jv08201


 In response to msg 49452 by  Bibliobiftek
view thread

Re: FORWARD II ASCO Abstract

Background: IMGN853 is an antibody-drug conjugate targeting the folate receptor alpha (FOLR1), linked to maytansinoid, DM4. IMGN853 has promising single agent activity in FOLR1+ EOC. The recommended phase 2 dose (RP2D) is 6 mg/kg, based on adjusted ideal body weight (AIBW) IV every 3 wks. This study evaluates IMGN853 and G. Methods: Patients (pts) with FOLR1+ tumors including: platinum resistant EOC with ≤4 prior chemotherapy (CT) regimens, EC with ≤2 CT and TNBC ≤4 CT are eligible. FOLR1 + is defined as ≥25% of tumor staining (all tumors) ≥2+ intensity (EOC, EC) and ≥1+ (TNBC). A standard 3+3 design combines IMGN853 and G. EOC pts undergo one research biopsy to assess intratumoral vs. circulating DM4 level and biopsy vs. archival tissue FOLR1 expression. Dose-limiting toxicity (DLT) is assessed during cycle 1. Responses as per RECIST 1.1 are assessed at 12 wks. and adverse events (AEs) are evaluated by CTCAE v4.0. Results: From 10/2017 to 1/2019 a total of 15 pts. were treated (3 additional pts have consented on dose level [DL] 4):10 EOC, 3 EC and 2 TNBC. One pt. on DL1 had grade (G) 4 thrombocytopenia (PLT) DLT. Three pts were inevaluable for DLT and were replaced: 1 pt. at DL1 with G4 neutropenia without fever of unknown duration due to delayed follow up blood work, 1 pt. at DL2 and 1 pt. at DL3 due to incomplete cycle 1. No DLTs were observed on DL2-3. Day 8 cycle 1 dose modifications were required in 3 of 4 patients on DL3 (for mucositis [1 pt.], and PLT [2 pts]). We are now enrolling at the RP2D for both agents, and MTD will be determined prior to May 2019. Conclusions: IMGN853 in combination with G is achievable at clinically relevant doses and the recommended Phase 2 dose and MTD will be reported. Support: NCCN grant; with support from ImmunoGen Corp and Cancer Center Support Grant P30CA033572. Clinical trial information: NCT02996825
DLIMGN853
(mg/kg, AIBW) D1q3W)
Gemcitabine
(mg/m2, D1D8q3W)
Evaluable/TreatedDLTsResponses
15 mg/kg IV, day 1600 mg/m2 IV, d1,86/71 G4 PLT3 PR (2 EOC+1 EC)
26 mg/kg IV, day 1600 mg/m2 IV, d1, 83/4None1 PR (1 TNBC)
36 mg/kg IV day 1800 mg/m2 IV, d1, 83/4None2 PR (2 EOC)
46 mg/kg IV, day 11000 mg/m2 IV, d1,8 83 consented--


     e-mail to a friend      printer-friendly     add to library      
| More
Recs: 0     Views: 235
Previous Message  Next Message   Post Message   Post a Reply return to message boardtop of board


About Us  �  Contact Us  �  Follow Us on Twitter  �  Members Directory  �  Help Center  �  Advertise
Not a member yet? What are you waiting for? Create Account
Want to contribute? Support InvestorVillage by donating
� 2003-2018 Investorvillage.com. All rights reserved. User Agreement
   
Financial Market Data provided by
.


Loading...