Response rate

Emapalumab's efficacy confirmed by sensitivity analysis presented at ESID2020

Saturday, October 17, 2020 - 1:33pm

"We remain committed to making emapalumab accessible to patients affected by this severe condition around the world."

Key Points: 
  • "We remain committed to making emapalumab accessible to patients affected by this severe condition around the world."
  • A high unmet medical need exists among these patients despite today's standard-of-care therapy, glucocorticoids and etoposide, with or without cyclosporine.
  • The pivotal study used clinically objective response criteria to define the primary endpoint of overall response rate to emapalumab in primary HLH.
  • The sensitivity analysis supports the use of the clinically objective ORR as a primary endpoint in studies of primary HLH.

Census Bureau Hosts 2020 Census News Briefing

Thursday, July 2, 2020 - 7:57pm

What: The U.S. Census Bureau will hold a telephone news conference to share status updates on the 2020 Census.

Key Points: 
  • What: The U.S. Census Bureau will hold a telephone news conference to share status updates on the 2020 Census.
  • Topics of discussion include adjustments made to 2020 Census field operations due to COVID-19 , current response rates, and upcoming 2020 Census operations including the Nonresponse Followup Operation .
  • Access: The news briefing will consist of an audio conference only.
  • Interviews: Please contact the Census Bureaus Public Information Office at or call 301-763-3030 to request an interview.

Karyopharm Announces Publication of XPOVIO® (Selinexor) Phase 2b SADAL Study Results in The Lancet Haematology

Wednesday, June 24, 2020 - 12:00pm

In this population, single-agent oral XPOVIO (selinexor) demonstrated an overall response rate of 28%, including a complete response rate of 12%.

Key Points: 
  • In this population, single-agent oral XPOVIO (selinexor) demonstrated an overall response rate of 28%, including a complete response rate of 12%.
  • The published results are based on the multi-center, single-arm Phase 2b SADAL study (NCT02227251), which evaluated 127 patients (median of 2 prior treatment regimens) with RR DLBCL.
  • Patients received a fixed 60 mg dose of XPOVIO given orally twice weekly for a four-week cycle.
  • The SADAL study met its primary endpoint of overall response rate (ORR) with an ORR of 28%, including 15 complete responses (CRs) and 21 partial responses (PRs).

50% Complete Response Rate Observed in YourVaccx™ Study for Patients with Metastatic Prostate Cancer was Presented at the AACR Virtual Annual Meeting II

Monday, June 22, 2020 - 2:00pm

The patients were assessed after the completion of therapy, which varied from between 1 and 3 cycles of treatment.

Key Points: 
  • The patients were assessed after the completion of therapy, which varied from between 1 and 3 cycles of treatment.
  • All responses to therapy were assessed by RECIST v. 1.1 and metastatic prostate cancer patients were also assessed by serum PSA levels.
  • For all evaluable patients, the PoC study data showed a 38% (9/24) complete response rate (CR) and a 4% (1/24) partial response rate (PR), for an objective response rate (ORR) of 42% (10/24).
  • is now available at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting II.

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

Wednesday, April 22, 2020 - 10:01pm

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

Friday, October 25, 2019 - 1:30pm

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

Monday, September 30, 2019 - 1:30pm

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

Monday, September 16, 2019 - 1:00pm

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

Monday, September 16, 2019 - 1:00pm

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

Friday, September 13, 2019 - 7:37pm

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.