Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Fluoropyrimidine (FP) + bevacizumab (BEV) + atezolizumab vs FP/BEV in BRAFwt metastatic colorectal cancer (mCRC): Findings from Cohort 2 of MODUL – a multicentre, randomized trial of biomarker-driven maintenance treatment following first-line induction therapy

Date

22 Oct 2018

Session

Proffered paper session - Gastrointestinal tumours, colorectal

Presenters

Axel Grothey

Authors

A. Grothey1, J. Tabernero2, D. Arnold3, A. De Gramont4, M.P. Ducreux5, P.J. O'Dwyer6, E. van Cutsem7, I. Bosanac8, S. Srock8, C. Mancao8, F. Gilberg8, J. Winter8, H. Schmoll9

Author affiliations

  • 1 Division Of Medical Oncology, West Cancer Center, 38138 - Germantown/US
  • 2 Medical Oncology, Vall d’Hebron University Hospital. Vall d’Hebron Institute of Oncology VHIO., 08035 - Barcelona/ES
  • 3 2. Med. Abteilung, Asklepios Klinik Altona, 22763 - Hamburg/DE
  • 4 Medical Oncology, Institut hospitalier Franco-Britannique, 92300 - Levallois Perret/FR
  • 5 Medical Oncology, Gustave Roussy - Cancer Campus, 94805 - Villejuif/FR
  • 6 Medical Oncology, University of Pennsylvania, 19104 - Philadelphia/US
  • 7 Digestive Oncology, University Hospitals Gasthuisberg/Leuven and KULeuven, 3000 - Leuven/BE
  • 8 Medical Affairs, F. Hoffmann-La Roche Ltd, Basel/CH
  • 9 Medical Oncology, Martin-Luther-University, Halle/DE
More

Resources

Background

In patients (pts) with mCRC, molecular screening approaches and new biomarkers are required to fully characterize tumours and identify those likely to benefit. The MODUL study (ClinicalTrials.gov: NCT02291289) is highly adaptable, Phase II signal seeking, and evaluates the theory of tumoural heterogeneity under induction chemotherapy via switch maintenance treatment in first-line mCRC.

Methods

MODUL follows an umbrella design; pts with measurable, unresectable, previously untreated mCRC receive 16 weeks of induction treatment with FOLFOX + BEV followed by maintenance randomized to either control (FP/BEV) or experimental treatment in one of four cohorts. Here we report results of Cohort 2 (BRAFwt: FP/BEV + atezolizumab). Primary efficacy endpoint: progression-free survival (PFS, per investigator). Secondary endpoints: overall survival (OS); best overall response rate (ORR); disease control rate (DCR); time to treatment response (TTR); duration of response (DoR); ECOG performance status (PS); safety.

Results

824 pts were screened, 696 of whom were enrolled to receive induction treatment. 445 pts with BRAFwt mCRC were randomized to maintenance treatment in Cohort 2 (297 pts FP/BEV + atezolizumab; 148 pts FP/BEV). In the primary analysis of Cohort 2 (median follow-up 10.5 months), PFS was not met (HR=0.92; 95% CI 0.72–1.17; p=0.48) and OS was immature. ORR, DCR, TTP and DoR showed small numerical differences in favour of experimental treatment. Subgroup treatment interactions were observed for gender, ECOG PS, response at end of induction and initial diagnosis (synchronous vs metachronous disease). In the updated analysis (median follow-up 18.7 months), PFS outcome was unchanged (HR=0.96; 95% CI 0.77–1.20; p=0.727) and OS with 51% of pts with an event was HR=0.86; 95% CI 0.66–1.13; p=0.28. The safety profiles observed are consistent with previous findings with no new safety signals identified.

Conclusions

Adding atezolizumab to FP/BEV (standard of care) as first-line maintenance treatment for pts with BRAFwt mCRC did not lead to improvement in efficacy outcomes.

Clinical trial identification

ClinicalTrials.gov: NCT02291289

Editorial Acknowledgement

Editorial assistance was provided by Lee Miller (Miller Medical Communications).

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings