Clinical endpoint

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.

Combination Study with JS016 and LY-CoV555 for Patients with Mild-to-Moderate COVID-19 Symptoms Met Primary and Secondary Endpoints

Thursday, October 8, 2020 - 3:50am

Lilly intends to submit a request for Emergency Use Authorization (EUA) for the combination therapy in patients with mild-to-moderate COVID-19 in November 2020.

Key Points: 
  • Lilly intends to submit a request for Emergency Use Authorization (EUA) for the combination therapy in patients with mild-to-moderate COVID-19 in November 2020.
  • The combination therapy significantly reduced viral load at day 11 (p=0.011), meeting the primary endpoint of the study.
  • No emergent putative resistance variants have been observed thus far in patients treated with combination therapy.
  • Combination therapy also met prespecified clinical endpoints, including the time-weighted average change from baseline in total symptom score from day 1 to 11 (p=0.009).

Corbus Pharmaceuticals Announces Phase 2b Study of Lenabasum for Treatment of Cystic Fibrosis Did Not Meet Primary Endpoint

Tuesday, October 6, 2020 - 12:05pm

The CF-002 Phase 2b trial did not meet the primary endpoint of a statistically significant reduction in rate of new PEx per subject per 28 weeks.

Key Points: 
  • The CF-002 Phase 2b trial did not meet the primary endpoint of a statistically significant reduction in rate of new PEx per subject per 28 weeks.
  • Barbara White, M.D., Chief Medical Officer and Head of Research of Corbus, said, We are very disappointed that the study did not meet the primary endpoint.
  • We thank the participants, the staff at study sites, the Cystic Fibrosis Foundation, and the European Cystic Fibrosis Society Clinical Trials for their support and partnership throughout this study.
  • The Phase 2b CF study was funded in part by a Development Award for up to $25 Million from the Cystic Fibrosis Foundation.

miRagen Announces Internal Review of Preliminary Topline Data for the Phase 2 SOLAR Clinical Trial of Cobomarsen in Patients with Cutaneous T-Cell Lymphoma (CTCL)

Monday, October 5, 2020 - 9:05pm

Progression free survival (PFS), a secondary endpoint for the study, indicates a treatment effect in favor of cobomarsen.

Key Points: 
  • Progression free survival (PFS), a secondary endpoint for the study, indicates a treatment effect in favor of cobomarsen.
  • The SOLAR study was designed to evaluate the safety and efficacy of cobomarsen given by intravenous infusion in an active control comparison trial for patients with the mycosis fungoides subtype of CTCL.
  • We have completed this preliminary evaluation and will continue to analyze the final topline data and other secondary SOLAR data as we seek a partner for cobomarsen, stated Ms. Lee Rauch, President and Chief Executive Officer.
  • miRagen undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law.

Nexstim Continues to Report Promising Results in Quickly Growing Number of Patients Completing SmartFocus® rTMS Treatment of Major Depressive Disorder

Monday, October 5, 2020 - 11:30am

Treatment outcomes of these 108 patients were good: 42 % were in remission at end of treatment and 74 % obtained a clinical response.

Key Points: 
  • Treatment outcomes of these 108 patients were good: 42 % were in remission at end of treatment and 74 % obtained a clinical response.
  • The clinical outcomes of majority of the patients treated with SmartFocus rTMS in the United States are being collected in a registry the information is provided by participating clinical sites using Nexstims SmartFocus technology.
  • The number of patients who are being treated with Nexstim SmartFocus rTMS is growing fast.
  • Mikko Karvinen, CEO of Nexstim, said: We are very happy to continue reporting these very promising clinical results on the use of our SmartFocus rTMS for major depressive disorder.

JUPITER-02 Phase III Global Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival in Recurrent or Metastatic Nasopharyngeal Carcinoma

Tuesday, September 29, 2020 - 3:35am

Nasopharyngeal carcinoma (NPC), a subtype of head and neck cancer, is a malignant tumor that occurs in the nasopharynx.

Key Points: 
  • Nasopharyngeal carcinoma (NPC), a subtype of head and neck cancer, is a malignant tumor that occurs in the nasopharynx.
  • At the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the global study met its primary endpoint of progression free survival (PFS).
  • Compared with the placebo control, Toripalimab in combination with Gemcitabine/Cisplatin significantly prolonged the PFS as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.
  • In September 2020, Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA.

AC Immune Reports Top Line Results from TAURIEL Phase 2 Trial Evaluating Semorinemab in Early Alzheimer’s Disease

Wednesday, September 23, 2020 - 12:00pm

Two secondary endpoints, Alzheimers Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimers Disease Cooperative Study Group Activities of Daily Living Inventory (ADCS-ADL) were also not met.

Key Points: 
  • Two secondary endpoints, Alzheimers Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimers Disease Cooperative Study Group Activities of Daily Living Inventory (ADCS-ADL) were also not met.
  • Additional data analyses are ongoing and Genentech plans to present the results from TAURIEL at an upcoming medical congress.
  • The Phase 2 TAURIEL study of semorinemab is a 73-week, double-blind, placebo-controlled trial to determine if it can slow the rate of clinical decline in early (prodromal to mild) AD.
  • Two secondary endpoints, Alzheimers Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13) and Alzheimers Disease Cooperative Study Group Activities of Daily Living Inventory (ADCS-ADL) also were not met.

Eisai and Merck Present First-Time Data From Two Studies Evaluating KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) in Seven Different Tumor Types at ESMO Virtual Congress 2020

Wednesday, September 23, 2020 - 1:10am

The primary endpoint is ORR per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR).

Key Points: 
  • The primary endpoint is ORR per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as assessed by blinded independent central review (BICR).
  • Secondary endpoints include progression-free survival (PFS) and
    duration of response (DOR) per RECIST v1.1 by BICR, overall survival (OS) and safety.
  • At data cutoff (June 10, 2020), a total of 103 patients were enrolled and treated.
  • LEAP-005 (ClinicalTrials.gov, NCT03797326) is a Phase 2, single-arm, open-label trial evaluating LENVIMA in combination with KEYTRUDA in patients with select previously treated advanced solid tumors.

Genmab and Seattle Genetics Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2020

Monday, September 21, 2020 - 3:20pm

Genmab A/S (Nasdaq: GMAB) and Seattle Genetics, Inc. (Nasdaq: SGEN) today presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Key Points: 
  • Genmab A/S (Nasdaq: GMAB) and Seattle Genetics, Inc. (Nasdaq: SGEN) today presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
  • Tisotumab vedotin has demonstrated meaningful clinical activity in patients with recurrent and/or metastatic cervical cancer for whom there is a high unmet need for new therapies, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.
  • Data presented at ESMO include the primary endpoint of confirmed ORR as assessed by independent central review in 101 patients treated with tisotumab vedotin in the trial.
  • For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

Agios Announces Final Overall Survival Data from Phase 3 ClarIDHy Study of TIBSOVO® (ivosidenib tablets) in Previously Treated IDH1-Mutant Cholangiocarcinoma Patients

Monday, September 21, 2020 - 12:00pm

OS was a secondary endpoint in the ClarIDHy study; as previously announced , the study met its primary endpoint of progression-free survival (HR 0.37, p-value

Key Points: 
  • OS was a secondary endpoint in the ClarIDHy study; as previously announced , the study met its primary endpoint of progression-free survival (HR 0.37, p-value
  • The ClarIDHy trial is a global, randomized Phase 3 trial in previously treated IDH1-mutant cholangiocarcinoma patients who have documented disease progression following one or two systemic therapies in the advanced setting.
  • As of the May 30, 2020 data cutoff, 185 patients were randomized, with 124 patients in the TIBSOVO arm and 61 patients in the placebo arm.
  • TIBSOVOis not approved in any country for the treatment of patients with previously treated advanced IDH1-mutant cholangiocarcinoma.