BIG MSS-CRC TRIAL NEWS
A VERY IMPORTANT new Phase 3 immunotherapy trial has been registered to start soon for CRC – details below.
Print out the links to have an informed discussion with your MD(s) to determine if it would be a good part of your treatment plan.
Full data is being released in an oral presentation at ASCO on Sunday, hopefully a publication will arrive soon.
NCT02788279: https://clinicaltrials.gov/ct2/show/NCT ... 279&rank=1
Based upon the Cobimetinib (MEK inhibitor) + Atezolizumab (PDL1 inhibitor immunotherapy) Phase 1 trial whose full results are coming out at ASCO on Sunday http://abstracts.asco.org/176/AbstView_176_171295.html
Preclinical rationale: http://www.cell.com/immunity/abstract/S1074-7613(16
Presumably based upon their belief in the strength of the Phase 1 data – the developing company is SKIPPING PHASE 2 and going directly into a randomized PHASE 3 trial set up for accelerated FDA approval – IF PHASE 3 DATA SUPPORTS.
Phase 3 trial details:
- 360 patients across 42 locations
- 3-arm randomized study (1/3 chance of getting each arm by luck of draw). Arm 1: Patients will get Atexolizumab (PDL1 inhibitor alone). Arm 2: Patients will get Cobimetinib + Atezolizumab Arm 3: Patients will get current standard of care Regorafenib as comparator
- ENROLLMENT MIMICKING NATURAL STAGE IV CRC PATIENT POPULATION (50% KRAS-wildtype, rest KRAS-mutant; 5% MSI-high, rest MSS) – implies that they are attempting to get a very general FDA approval for “Stage IV CRC”.
- Relatively lenient in terms of past chemotherapy. Need to have either failed or been “intolerant to” two lines of chemo prior to trial.
- Can NOT have taken previously any of these: 1.) ANY immunotherapy 2.) Any MEK inhibitor 3.) Regorafenib
- Can not have had a second cancer within 3 years
- Can not have a history autoimmune disease
- Additional exclusions apply (listed in the NCT link above)
Overall – there are some aspects which are not ideal for a current patients (e.g. some of the exclusion criteria, randomization) – but this is an ideal set up for fast FDA approval to bring an immunotherapy to the MSS-CRC masses ASAP (IF PHASE 3 DATA SUPPORTS!)
I’ve been pounding my fist for a long time that I strongly believed combination therapy tricks would work in MSS-CRC. This is the next BIG STEP FORWARD to prove that belief clinically!
Same combination I blogged about last week: https://adventuresinlivingterminallyopt ... al-cancer/
A very good day for MSS-CRC that the developing company feels strongly enough about their Phase 1 data to “go for” an accelerated approval.
Crossing fingers now that the Phase 3 data turns out well…
6/4/2012 Dx Stage 3C CRC @ 40 yo. MSS, KRAS-WT, BRAF-WT, p53-mut
8/13 Enlarged lymphs - Stable
10/14 Stage IV. Lung & Lymph mets. 5-FU+bev
11/15 FOLFIRI + bev
11/16 Signs of FOLFIRI resistance (Lymph mets)
1/17 Palliative radiation for resistant mets
2/17 FOLFIRI + bev + Maraviroc (off-label)
3/17 FOLFIRI + Erbitux + Maraviroc (off-label)MSS-CRC Clinical Trial Finder: http://trialfinder.fightcrc.org/2016 Colondar 2.0 ModelDK37 Science Posts List