Response rate

Incyte Announces Pivotal REACH2 Study Data Published in NEJM Highlight Superior Efficacy of Ruxolitinib (Jakafi®) versus Best Available Therapy in Patients with Acute Graft-Versus-Host Disease

Retrieved on: 
Wednesday, April 22, 2020
Stem cells, Biotechnology, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical trials, Medicine, Medical specialties, Chemical compounds, Transplantation medicine, Pyrazoles, Graft-versus-host disease, Ruxolitinib, Clinical endpoint, Response rate, REACH2, REACH, Jakafi® (ruxolitinib), Incyte

The results of REACH2, the first Phase 3 study of ruxolitinib in acute GVHD to have met its primary endpoint, reinforce findings from the previously-reported Phase 2 REACH1 study.

Key Points: 
  • The results of REACH2, the first Phase 3 study of ruxolitinib in acute GVHD to have met its primary endpoint, reinforce findings from the previously-reported Phase 2 REACH1 study.
  • In REACH2, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) vs.
  • For the key secondary endpoints, patients treated with ruxolitinib maintained significantly higher durable ORR (40% vs. 22%; p
  • Randomized Phase 3 Trial Evaluating the Efficacy and Safety of Ruxolitinib vs Best Available Therapy in Patients with Steroid-Refractory Acute Graft vs Host Disease (aGVHD).

Zai Lab Partner, MacroGenics, Announces Initiation of Phase 2/3 MAHOGANY Study of Margetuximab in Gastric or Gastroesophageal Junction Cancer

Retrieved on: 
Friday, October 25, 2019
Health, Medicine, Cancer, Cancer research, Oncology, Response Evaluation Criteria in Solid Tumors, Medical terminology, Clinical trial, Margetuximab, Response rate, Immune-related response criteria

The Phase 2/3 clinical trial is planned to be conducted at clinical sites globally, in collaboration with Zai Lab, the regional partner in Greater China.

Key Points: 
  • The Phase 2/3 clinical trial is planned to be conducted at clinical sites globally, in collaboration with Zai Lab, the regional partner in Greater China.
  • Based on Cancer Statistics in China 2015, the annual incidence for gastric cancer is approximately 680,000 in China.
  • The primary outcome measure for efficacy is objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST).
  • This press release contains statements about future expectations, plans and prospects for Zai Lab, including plans for commercializing margetuximab in China.

Cellectar Presents Data from DLBCL Cohort of its Phase 2 CLOVER-1 Study at the European Society for Medical Oncology (ESMO) Congress

Retrieved on: 
Monday, September 30, 2019
Branches of biology, Oncogenes, Oncology, Bcl-2, Programmed cell death, Myc, Response rate

Data showed durable responses, including a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and a 50% clinical benefit rate (CBR).

Key Points: 
  • Data showed durable responses, including a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and a 50% clinical benefit rate (CBR).
  • In a patient for whom cytogenetics was available, CLR 131 showed activity against c-Myc and BCL-2 mutation (single & dual-hit) positive patients.
  • Cellectar was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the trial.
  • The companys lead PDC therapeutic, CLR 131, is currently in three clinical studies a Phase 2 study, and two Phase 1 studies.

Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Monday, September 16, 2019
Health, Cancer, Medicine, Pharmaceuticals policy, Prescription Drug User Fee Act, Transitional cell carcinoma, Seattle Genetics, Transitional epithelium, Food and Drug Administration, Priority review, Bladder cancer, Response rate

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020.
  • "The FDA's filing of the application for enfortumab vedotin and granting of Priority Review is a significant milestone toward offering a new treatment to patients with advanced urothelial cancer who have a clear unmet need," said Roger Dansey, M.D., Chief Medical Officer atSeattle Genetics.
  • In cohort 1, 128 patients were enrolled at multiple centers internationally.2 The primary endpoint is confirmed objective response rate per blinded independent central review.
  • Urothelial cancer is the most common type of bladder cancer (90 percent of cases).

Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Monday, September 16, 2019
Research, Sports, Pharmaceutical, Oncology, Science, Clinical trials, Biotechnology, FDA, Health, Health, Cancer, Medicine, Pharmaceuticals policy, Prescription Drug User Fee Act, Transitional cell carcinoma, Seattle Genetics, Transitional epithelium, Bladder cancer, Response rate, Priority review, Food and Drug Administration, the EV-201 Trial, Urothelial Cancer, Enfortumab Vedotin, Seattle Genetics, Astellas, the Astellas and Seattle Genetics Collaboration

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020.
  • The FDAs filing of the application for enfortumab vedotin and granting of Priority Review is a significant milestone toward offering a new treatment to patients with advanced urothelial cancer who have a clear unmet need, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.
  • In cohort 1, 128 patients were enrolled at multiple centers internationally.2 The primary endpoint is confirmed objective response rate per blinded independent central review.
  • Urothelial cancer is the most common type of bladder cancer (90 percent of cases).

Candidates Who Weren't Hired Still Love Compassion International

Retrieved on: 
Friday, September 13, 2019
Ethics, Applied ethics, Articles, Giving, Moral psychology, Compassion, Kindness, Virtue, Response rate

Talent Board surveys job candidates regarding their experience during the interview process for a position with a company.

Key Points: 
  • Talent Board surveys job candidates regarding their experience during the interview process for a position with a company.
  • To qualify, each company must have a high response rate from candidates who were not hired.
  • Nearly 2,000 job candidates were interviewed on behalf of Compassion.
  • Founded in 1952, Compassion International is a Christian child development organization that works to release children from poverty in Jesus' name.

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

Retrieved on: 
Thursday, August 15, 2019
Oncology, Biomarker, Cell biology, Response rate

We're seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine," said FDA Acting Commissioner Ned Sharpless, M.D.

Key Points: 
  • We're seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine," said FDA Acting Commissioner Ned Sharpless, M.D.
  • The proportion of patients with substantial tumor shrinkage (overall response rate) was 57%, with 7.4% of patients having complete disappearance of the tumor.
  • Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for nine months or longer.
  • Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.

Civis Analytics Unveils Tools for a Successful 2020 Census

Retrieved on: 
Thursday, January 24, 2019
Psychometrics, Survey Methodology, Measurement, Product testing, Quantitative research, Census, Response rate, Civis, Research methods, Assumption

"Our new research shows 20% of Americans are unlikely to answer the 2020 Census -- and that's optimistic compared to other research .

Key Points: 
  • "Our new research shows 20% of Americans are unlikely to answer the 2020 Census -- and that's optimistic compared to other research .
  • Civis utilizes the upcoming Census Barriers, Attitudes, and Motivators Study (CBAMS) study to shape these surveys to a local audience.
  • Civis has begun conducting national tests on a variety of Census message options, described below, and discovered that the right outreach can increase Census 2020 response as much as 8%.
  • Also released today, Civis tested what messaging most improves 2020 Census response rates using its Creative Focus technology.