Entries by clickgiant

Keytruda Monotherapy Approved for 2L+ Esophageal Cancer

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 […]

Novartis’ PARAGON-HF Trial Evaluating Entresto in HFpEF Misses Primary Endpoint

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 […]

Phase 3 CheckMate – 227 update in 1L NSCLC: survival benefit with Opdivo/Yervoy but not Opdivo/chemotherapy

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 […]

FDA Approves Gene Therapy for Spinal Muscular Atrophy

July 23, 2019 Impact: High Zolgensma is approved for the treatment of pediatric patients less than 2 years of age with SMA including those who are pre-symptomatic at diagnosis. Zolgensma is designed to address the genetic root cause of SMA by replacing the defective or missing SMN1 gene to halt disease progression with a single, […]

BeiGene’s Tislelizumab Granted Priority Review in China for Urothelial Carcinoma

July 23, 2019 Impact: Moderate BeiGene has announced that the China NMPA (National Medical Products Administration) has granted Priority Review status to the sNDA for tislelizumab (anti-PD-1; Fc-engineered) for patients with previously treated locally-advanced or metastatic urothelial carcinoma (UC). The filing is supported by data from a pivotal Phase 2 study in 113 PD-L1+ Chinese […]

Keytruda receives FDA accelerated approval for 3L SCLC

June 18, 2019 Impact Level: High FDA has granted accelerated approval to Keytruda (pembrolizumab) monotherapy for 3L treatment of metastatic SCLC. According to Keytruda’s revised label, it is indicated for use after platinum-based chemotherapy and one other line of therapy. This approval is based on pooled data from the KEYNOTE-158 (Phase 2) and KEYNOTE-028 (Phase […]

Keytruda Monotherapy Fails in Phase 3 TNBC Trial

May 20, 2019 Impact Level: Moderate Merck has announced that its Phase 3 KEYNOTE-119 trial assessing Keytruda (pembrolizumab) monotherapy compared to chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine) in 2L and 3L metastatic triple-negative breast cancer (TNBC) patients did not meet the primary endpoint of OS. In accordance with the study protocol, other endpoints (PFS, ORR, […]

Myovant Reports Phase 3 Data of Relugolix in Uterine Fibroids

May 14, 2019 Impact Level: Moderate The LIBERTY 1 study met its primary efficacy endpoint with 73.4% of women receiving once daily oral relugolix combination therapy achieving the responder criteria compared with 18.9% of women receiving placebo (p < 0.0001). Response was defined as a menstrual blood loss volume of less than 80 mL and […]