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NSCLC: KOL Insight

NSCLC: KOL Insight

Introduction

CheckMate-026 results are in. Will Opdivo’s failure open up the field for rival immunotherapies?

News that the CheckMate-026 trial failed to meet its primary endpoint has left stakeholders scrambling to sort out what the results mean for Opdivo, and whether Keytruda will become the first-line PD-1/L1 inhibitor.

Based on interviews with 12 key opinion leaders (KOLs), the report covers 13 marketed drugs and 9 in the pipeline. It explores the changing first-line treatment landscape, the likely impact of immunotherapy combinations, the evolving role of standard-of-care treatments like Tagrisso and Alecensa, and the potential for PD-1/L1 inhibitors in earlier settings.

Plus: A special addendum, produced just days after the CheckMate-026 announcement, provides early KOL insight into the trial’s near-term market impact.
Reasons to Purchase

Special Feature: KOLs weigh in on CheckMate-026 results

In the run up to publication, Bristol-Myers Squibb announced that the CheckMate-026 trial had failed to meet its primary endpoint. Over the next seven days, we spoke to three of the US KOLs originally interviewed for this report. A special addendum includes their insights, and answers key questions like:

  • Can we turn the hype down, please? Is an overly positive view of Opdivo driving overly dire reactions to the CheckMate-026 announcement? What does Opdivo’s failure really mean for BMS, and for the use of PD-1/L1 inhibitors?
  • Did BMS make a strategic blunder? The strategy that helped Opdivo capture the second-line treatment market fell short in the first-line setting. What do KOLs think BMS should have done differently?
  • What’s next for Opdivo? Opdivo is down, but not out, KOLs say. What opportunities still exist for BMS in first-line NSCLC treatment, and what will it take to seize them?
Top takeaways
  • PD-1/L1 inhibitors shaking up first-line treatment: Rivals Keytruda and Opdivo are battling for top spot. Will the CheckMate-026 results hand Merck & Co. a decisive win? If so, what can BMS do to stay in the game? Can other PD-1/L1 inhibitors gain a foothold?
  • Combination therapies on the way: Several companies are investing in immunotherapy combinations. What will determine their use? Which ones are most likely to succeed? Will they unseat the reigning monotherapies?
  • Downstream consequences: Some KOLs say that a shakeup in first-line treatment will have an impact on the second-line landscape as well. What knock-on effects do they anticipate and how will those affect Opdivo’s dominant position?
  • Branching out: Some PD-1/L1 inhibitors are being evaluated for use in adjuvant and stage III settings, but their prospects hinge on the answers to a few key questions. Which clinical trials will provide them?
  • Climbing the treatment algorithm: Beyond the PD-1/L1 landscape, KOLs are keeping a close eye on treatments for EGFR mutation-positive, and ALK positive NSCLC that have the potential to move up to first-line use. What will determine their prospects?
Brands covered

Marketed Drugs

Immunotherapies
  • Opdivo (nivolumab; BMS)
  • Keytruda (pembrolizumab; Merck & Co.)
EGFR mutation-positive NSCLC
  • Gilotrif/Giotrif (afatinib; Boehringer Ingelheim)
  • Iressa (gefitinib; AstraZeneca)
  • Tarceva (erlotinib; Astellas)
  • Tagrisso (osimertinib; AstraZeneca)
ALK-positive NSCLC
  • Xalkori (crizotinib; Pfizer)
  • Zykadia (ceritinib; Novartis)
  • Alecensa (alectinib; Roche)
ALK and EGFR mutation-negative NSCLC
  • Avastin (bevacizumab; Roche)
  • Vargatef (nintedanib; Boehringer Ingelheim)
  • Cyramza (ramucirumab; Eli Lilly)
  • Portrazza (necitumumab; Eli Lilly)
Pipeline Drugs

Immunotherapies
  • Atezolizumab (RG7446; Genentech/Roche)
  • Durvalumab (MEDI4736; AstraZeneca)
  • Yervoy (ipilimumab; BMS)
  • Avelumab (MSB0010718C/PF-06834635; Merck Group/Pfizer)
  • Plinabulin (NPI-2358; BeyondSpring)
EGFR mutation-positive NSCLC
  • Rociletinib (CO-1686; Celgene Corporation/Clovis Oncology)
ALK-positive NSCLC
  • Brigatinib (AP26113; ARIAD)
ALK and EGFR mutation-negative NSCLC
  • Abemaciclib (LY2835219; Eli Lilly)
  • Selumetinib (AZD6244; Array BioPharma/AstraZeneca)
Key Opinion Leaders Interviewed for This Report

KOLs from North America
  • Catherine Azar, Clinical Associate Professor of Medicine, Hematology/ Oncology Department, University of Arizona, Tucson, AZ.
  • Paul Bunn, Distinguished Professor, Division of Medical Oncology, University of Colorado, Boulder, CO.
  • Renata Ferrarotto, Assistant Professor, Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • Edward Garon, Associate Clinical Professor, Thoratic Oncology Program, Department of Hematology and Oncology, David Geffen School of Medicine, University of California, Los Angeles, CA.
  • Jared Weiss, Assistant Professor, School of Medicine, University of North Carolina at Chapel Hill, Clinical Research, Thoracic Oncology Program, Chapel Hill, NC.
  • Howard West, Medical Director, Thoracic Oncology Program, Swedish Cancer Institute; President & CEO, Global Resource for Advancing Cancer Education (GRACE), Seattle, WA.
  • Anonymous KOL, Associate Professor at a major US Medical School.
KOLs from Europe
  • Qamar Ghafoor, Consultant Clinical Oncologist at University Hospital Birmingham, UK.
  • Jose I. Mayordomo, Medical Oncologist, Medical Oncology at the University Hospital of Zaragoza, Spain/Professor, Division of Medical Oncology, University of Colorado School of Medicine, Denver, CO, USA.
  • Marie Wislez, Consultant, Tenon Hospital, Paris, France.
  • 2 Anonymous German KOLs
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1.Executive summary
2.Addendum Bristol-Myers Squibb announces top-line results from CheckMate -026 a Phase III study of Opdivo (nivolumab) in treatment-naïve patients with advanced non-small cell lung cancer
3.Research objectives
4.Research focus
4.1.NSCLC treatment
5.Immunotherapy
5.1.Overview
5.2.Approved drugs
5.3.Opdivo (nivolumab; Bristol-Myers Squibb)
5.4.Keytruda (pembrolizumab; Merck & Co.)
5.5.Pipeline drugs
5.6.Atezolizumab (RG7446; Genentech/Roche)
5.7.Durvalumab (MEDI4736; AstraZeneca)
5.8.Yervoy (ipilimumab; Bristol-Myers Squibb)
5.9.Avelumab (MSB0010718C/PF-06834635; Merck Group/Pfizer)
5.10.Plinabulin (NPI-2358; BeyondSpring)
6.EGFR mutation-positive NSCLC
6.1.Approved drugs
6.2.Tarceva/Iressa/Gilotrif (Astellas/Roche/AstraZeneca/Boehringer Ingelheim)
6.3.Tagrisso (osimertinib; AstraZeneca)
6.4.Pipeline drugs
6.5.Rociletinib (CO-1686; Celgene/Clovis Oncology)
7.ALK-positive NSCLC
7.1.Overview
7.2.Approved drugs
7.3.Xalkori (crizotinib; Pfizer)
7.4.Zykadia (ceritinib; Novartis)
7.5.Alecensa (alectinib; Roche)
7.6.Pipeline drugs
7.7.Brigatinib (AP26113; ARIAD)
8.ALK and EGFR mutation-negative NSCLC
8.1.Overview
8.2.Approved drugs
8.3.Avastin (bevacizumab; Roche)
8.4.Vargatef (nintedanib; Boehringer Ingelheim)
8.5.Cyramza (ramucirumab; Eli Lilly)
8.6.Portrazza (necitumumab; Eli Lilly)
8.7.Pipeline drugs
8.8.Abemaciclib (LY2835219; Eli Lilly)
8.9.Selumetinib (AZD6244; Array/AstraZeneca)
9.Conclusion
9.1.Current and future treatment algorithm
9.2.Immunotherapies will move to the first-line setting
9.3.Potential for change in the first-line treatment of EGFRm+ NSCLC;
9.4.Tagrisso is well entrenched in second-line therapy
9.5.KOLs are enthusiastic about Alecensa’s place in second-line ALK-translocated NSCLC;
9.6.J-ALEX highlights a potential front-line role
9.7.A greater range of driver mutations could be specifically targeted
9.8.Opportunities for PD-1/L1 inhibitors in earlier settings
10.Appendix
10.1.KOL biographies
10.2.KOLS from North America
10.3.KOLs from Europe

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