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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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, one-time infusion.
  • Data from the Phase 3 STR1VE trial show prolonged event-free survival, increases in motor function and significant milestone achievement in patients with SMA Type 1, consistent with the Phase 1 START trial.
  • In the START trial, patients treated with Zolgensma achieved motor milestones never seen in the natural history of the disease, including sitting, talking and some patients walking, with no waning of effect nearly four years post-dosing.
  • AveXis has an exclusive, worldwide license with Nationwide Children’s Hospital to both the intravenous and intrathecal delivery of AAV9 gene therapy for the treatment of all types of SMA; has an exclusive, worldwide license from REGENXBIO for any recombinant AAV vector in its intellectual property portfolio for the in vivo gene therapy treatment of SMA in humans.

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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 and South Korean patients with previously treated locally or metastatic UC.

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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 1b) trials.

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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, disease control rate, and duration of response) were not formally tested since OS was not met.
  • Merck plans to present these results at an upcoming medical conference.

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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 a 50 percent or greater reduction from baseline in menstrual blood loss volume during the last 35 days of the 24-week treatment period.

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May 7, 2019

Impact level: Moderate

  • Sutro has provided updates on preclinical BCMA ADC and BCMA/CD3 bispecific antibody programs that are part of a Celgene immuno-oncology collaboration formed in 2014.

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April 25, 2019

Impact level: High

  • According to an updated label, FDA has granted accelerated approval to use of Keytruda (pembrolizumab; PD-1) in combination with Inlyta (axitinib; TKI) in 1L renal cell carcinoma (RCC).

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April 22, 2019

Impact Level: High

  • Novartis has contributed $75 million towards a Series C financing for CAR-T company Poseida, which totaled $142 million from current and new investors.

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