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NSCLC: Update Bulletin [November 2017]

Product Code:
Publication Date:
November 2017

This edition presents key opinion leader (KOL) views on recent developments in the non-small cell lung cancer (NSCLC) market. Topics covered include: the presentation of positive progression free survival (PFS) data from the Phase III PACIFIC trial of AstraZeneca's Imfinzi (durvalumab) in patients with locally advanced, unresectable, stage III NSCLC who have not progressed following standard platinum-based chemotherapy concurrent with radiation therapy; the approval of Roche’s Tecentriq (atezolizumab) in the EU for the treatment of patients with locally advanced or metastatic NSCLC following previous treatment with chemotherapy, regardless of PD-L1 status; the announcement by Merck & Co. that it has withdrawn its application seeking EU approval of Keytruda (pembrolizumab) as a first-line treatment for patients with metastatic, non-squamous NSCLC, in combination with doublet chemotherapy; the approval of the supplemental New Drug Application (sNDA) in the US for Genentech’s Alecensa (alectinib) as a first-line treatment of ALK-positive metastatic NSCLC as detected by an FDA-approved test.


Business Questions:

• How clinically significant are the positive PFS data recorded for Imfinzi in the PACIFIC trial in terms of treating locally advanced, unresectable NSCLC?
• Do KOLs anticipate that the PACIFIC trial will meet its OS endpoint?
• Assuming that Imfinzi gains approval for treating locally advanced, unresectable NSCLC, how likely is it that it will become the new standard of care (SOC) for this indication?
• How do KOLs view Tecentriq’s approval as a second-line treatment for advanced or metastatic NSCLC in Europe?
• What could help Tecentriq compete in the second-line setting?
• Are KOLs surprised by Merck & Co.’s decision to withdraw its EU marketing application for Keytruda plus chemotherapy in first-line therapy?
• To what extent will the outcome of the Phase III KEYNOTE-189 trial affect the success of Keytruda/chemotherapy as a treatment for NSCLC in the first-line setting?
• How do KOLs view the US approval of Alecensa as a first-line treatment for patients with ALK-positive metastatic NSCLC?
• How likely is it that Alecensa will replace Xalkori as SOC for patients with ALK-positive NSCLC in the first-line setting?
• Following progression on or after Alecensa, what would KOLs use to treat patients with ALK-positive NSCLC as second-line therapy and why?


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