August 21, 2019

Impact: High

Amgen announced that the U.S. District court of New Jersey ruled in favor of Amgen regarding the validity of two patents protecting exclusivity of Enbrel from biosimilars. 

Sandoz immediately announced that it would appeal the ruling.

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August 13, 2019

Impact: High

Get insight from inThought Research experts on the recent approval of Keytruda Monotherapy for 2L+ Esophageal cancer:

  • Merck has announced that FDA has approved Keytruda (pembrolizumab) as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 10), with disease progression after one or more prior lines of systemic therapy.
    • PD-L1 positivity will be determined by an FDA-approved companion diagnostic.
  • The approval is based on data from KEYNOTE-181 and KEYNOTE-180.
  • In KEYNOTE-181, the mOS for PD-L1+ esophageal squamous cell carcinoma (ESCC) patients treated with Keytruda was 10.3 months vs. 6.7 months in the chemotherapy arm (HR=0.64; p not provided).
    • The mPFS was 3.2 months for Keytruda treated patients vs. 2.3 months for the chemotherapy arm (HR=0.66, p not provided).
    • An ORR of 22% (CR rate=5%) was observed in Keytruda treated patients compared with 7% (CR rate=1%) in the chemotherapy arm.

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July 25, 2019

Impact: High

Get insight from inThought Research experts on Novartis results from the phase 3 PARAGON-HF clinical trial evaluating Entresto versus valsartan in HFpEF.

  • Novartis announced topline results from the phase 3 PARAGON-HF study evaluating Entresto versus valsartan in HFpEF.
  • The primary endpoint of reducing cardiovascular death and total heart failure hospitalizations did not reach reach statistical significance.
  • The data will be presented at the ESC Congress in September.
  • Scott Solomon M.D., the trial co-chair, noted that the full trial results may results in clinically meaningful benefits in patients with HFpEF and that the company will discuss next steps with clinical experts and regulators. 

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July 25, 2019

Impact: High

  • Bristol-Myers Squibb has provided updates on Part 1a and Part 2 of the Phase 3 CheckMate -227 study of Opdivo in 1L NSCLC.
  • Part 1a, which evaluated Opdivo and Yervoy vs. chemotherapy, met the co-primary endpoint of overall survival in patients with tumor expression levels of PD-L1 > 1%.
  • A survival benefit was also observed with Opdivo/Yervoy vs. chemotherapy alone in patients with tumors devoid of PD-L1 expression levels.
  • Part 2 of the study comparing Opdivo and chemotherapy to chemotherapy alone failed to meet the primary endpoint of overall survival (OS).
  • The mOS in patients treated with Opdivo/chemotherapy was 18.83 months vs. 15.57 months with chemotherapy alone. OS at 1 year was 67% with the combination vs. 59% with chemotherapy alone.
  • Data from this trial will be shared with regulatory authorities and be presented at a future medical conference.

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