Gain new KOL insights on the latest events happening in non-small cell lung cancer (NSCLC), including; the FDA accepting Merck and Co.’s regulatory filing for Keytruda (pembrolizumab) in combination with chemotherapy for the first-line treatment of metastatic or advanced NSCLC; AstraZeneca presenting positive late-stage results from the AURA3 trial of Tagrisso (osimertinib) at the 17th World Conference on Lung Cancer (WCLC 2016); data from the ASCEND-4 trial at WCLC 2016 showing that progression-free survival (PFS) was improved in patients with ALK-rearranged NSCLC treated with first-line Zykadia (ceritinib; Novartis), compared with chemotherapy; the European Commission approval of Roche’s Alecensa (alectinib) for the treatment of advanced ALK-positive NSCLC that has progressed following treatment with Xalkori (crizotinib; Pfizer).
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*Latest* Update 2: February 2017
Update 1: November 2016
Original Publication: June 2016
*Purchase of this report includes all updates*
This update tackles these key questions
- How do KOLs view the FDA filing for Keytruda plus chemotherapy as a first-line treatment for advanced NSCLC and the data supporting this?
- In which patients is the first-line combination of Keytruda plus chemotherapy likely to be used in?
- How do KOLs view the overall potential for the immunotherapies to be used in combination regimens for the first-line treatment of advanced NSCLC?
- How are the results from the AURA3 trial of Tagrisso viewed and what impact will these data have?
- How do KOLs rate the potential of Tagrisso as a first-line treatment for EGFR-mutation positive NSCLC?
- How will the ASCEND-4 trial data position Zykadia as a first-line therapy for patients with ALK-rearranged NSCLC?
- How do KOLs view the long-term prospects and positioning of Zykadia in the treatment of ALK-rearranged NSCLC, and how will it be impacted by next-generation ALK inhibitors?
- Following its EU approval, how do KOLs anticipate that Alecensa will be used in the EU and to what extent will it compete with Zykadia?
- What factors underlie Alecensa’s dominance in the second-line ALK-positive setting in the US and how do KOLs view its long term prospects?
Gain new KOL insights on the latest events happening in non-small cell lung cancer (NSCLC); the approval of Merck & Co.’s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression; the presentation of results from the KEYNOTE-021 trial of Keytruda in combination with pemetrexed (Alimta; Eli Lilly) for the first-line treatment of advanced NSCLC at the European Society for Medical Oncology (ESMO) 2016 Congress; the presentation of data from the CheckMate-026 trial of Bristol-Myers Squibb’s nivolumab (Opdivo) at ESMO 2016; the FDA approval of Roche’s Tecentriq (atezolizumab) for the treatment of NSCLC that has progressed following first-line therapy.
Original Publication: 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.
KOL Insight: NSCLC puts those questions in context with a detailed overview of the non-small cell lung cancer (NSCLC) treatment landscape. Request sample pages now
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.
Order the report and you’ll receive three quarterly FirstWord Therapy Trends Update Bulletins free!
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?
“[BMS] went for a home run and they didn’t get it, whether they got a single or double or triple or struck out, we don’t know.”
- US KOL
- 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?
- 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)
- 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)
- 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)
- 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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