2017 ASCO Annual Meeting!
Session: Breast Cancer—Local/Regional/Adjuvant
Type: Oral Abstract Session
Time: Monday June 5, 9:45 AM to 12:45 PM
Location: Hall D2
Pembrolizumab plus standard neoadjuvant therapy for high-risk breast cancer (BC): Results from I-SPY 2.
2017 ASCO Annual Meeting
J Clin Oncol 35, 2017 (suppl; abstr 506)
Author(s): Rita Nanda, Minetta C. Liu, Christina Yau, Smita Asare, Nola Hylton, Laura Van't Veer, Jane Perlmutter, Anne M. Wallace, Amy Jo Chien, Andres Forero-Torres, Erin Ellis, Heather Han, Amy Sanders Clark, Kathy S. Albain, Judy Caroline Boughey, Anthony D. Elias, Donald A. Berry, Douglas Yee, Angela DeMichele, Laura Esserman; I-SPY Network; The University of Chicago, Chicago, IL; The University of Texas MD Anderson Cancer Center, Houston, TX; Mayo Clinic, Rochester, MN; Masonic Cancer Center, University of Minnesota, Minneapolis, MN; Abramson Cancer Center, Philadelphia, PA; Buck Institute for Age Research, Novato, CA; Quantum Leap Health Care Collaborative, San Francisco, CA; UC San Francisco, San Francisco, CA; University of California, San Francisco, San Francisco, CA; Gemini Group, Ann Arbor, MI; University of California San Diego Moores Cancer Center, La Jolla, CA; University of Alabama at Birmingham, Birmingham, AL; Swedish Cancer Inst, Seattle, WA; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Hospital of the University of Pennsylvania, Philadelphia, PA; Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Maywood, IL; University of Colorado Comprehensive Cancer Center, Aurora, CO
Background: Pembro is an anti-PD-1 antibody with single agent activity in HER2– metastatic BC. I-SPY 2 is a multicenter, phase 2 platform trial which evaluates novel neoadjuvant therapies; the primary endpoint is pathological complete response (pCR, ypT0/Tis ypN0). We report current efficacy results, with final results at ASCO. Methods: Patients (pts) with invasive BC ≥2.5 cm by exam or ≥2 cm by imaging are assigned weekly paclitaxel x 12 (control) +/- an experimental agent, followed by doxorubicin/cyclophosphamide x 4. Combinations of hormone-receptor (HR), HER2, & MammaPrint (MP) status define the 8 signatures studied. MP low HR+ BC is excluded. Adaptive randomization is based on each arm’s Bayesian probability of superiority over control. Graduation by signature is based on an arm’s Bayesian predictive probability of a successful 1:1 randomized phase 3 trial with a pCR endpoint. We provide raw & Bayesian estimated pCR rates adjusted for covariates, time effects over the course of the trial, & serial MRI modeling for pts not yet assessed for pCR surgically. Results: 69 pts were randomized to pembro (HER2- subsets only) from Dec 2015 until it graduated in Nov 2016. 46 pts have undergone surgery (table); the other 23 have on-therapy MRI assessments. In 29 HR–/HER2– (TNBC) pts, pembro increased raw & estimated pCR rates by >50% & 40%, respectively; in 40 HR+/HER– pts, it did so by 13% and 21%. 5 pts had immune-related grade 3 adverse events (AEs); 1 hypophysitis & 4 adrenal insufficiency. 4 pts presented after completion of AC (149-179 d after starting pembro); 1 presented prior to AC (37 d after starting pembro). 7 pts had grade 1-2 thyroid abnormalities. Conclusion: Pembro added to standard therapy improved pCR rates in all HER2- BCs that meet I-SPY 2 eligibility, especially in TNBC. Immune-mediated AEs were observed; pt follow up is ongoing. Clinical trial information: NCT01042379
|Signature||Current raw data: |
|Estimated pCR rate |
(95% prob interval)
|Prob pembro |
|Pred prob of |
success in phase III
3. Double-blind, randomized phase III study to compare the efficacy and safety of CT-P6, trastuzumab biosimilar candidate versus trastuzumab as neoadjuvant treatment in HER2 positive early breast cancer (EBC).