Breakthrough therapy

Junshi Biosciences Receives Orphan Drug Designation from the U.S. FDA for Toripalimab for the Treatment of Soft Tissue Sarcoma

Thursday, September 17, 2020 - 11:00pm

The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.

Key Points: 
  • The FDA has previously granted Orphan Drug designation for Toripalimab for the treatment of mucosal melanoma and nasopharyngeal carcinoma.
  • Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types and obvious tumor heterogeneity.
  • The current clinical treatment of soft tissue sarcoma mainly uses cytotoxic anti-tumor drugs, which have significant adverse reactions and poor tolerance.
  • Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA in September 2020.

Halozyme Announces Poster Presentation Of Data From Roche's Phase 1b Study Evaluating Atezolizumab For Subcutaneous Administration Utilizing Enhanze® In Non-Small Cell Lung Cancer

Thursday, September 17, 2020 - 1:00pm

The Phase 1b dose-finding study enrolled 67 patients with advanced/metastatic NSCLC previously treated with chemotherapy (no prior cancer immunotherapy) in 3 cohorts.

Key Points: 
  • The Phase 1b dose-finding study enrolled 67 patients with advanced/metastatic NSCLC previously treated with chemotherapy (no prior cancer immunotherapy) in 3 cohorts.
  • The poster concluded that atezolizumab utilizing ENHANZE was well tolerated, provided similar exposure as atezolizumab IV and that results support further development of subcutaneous atezolizumab in IMscin001 Part 2, a confirmatory phase III study.
  • "We are pleased that the results from Roche's Phase 1b evaluating atezolizumab with ENHANZE support continued development in a Phase 3 study," said Dr. Helen Torley, president and chief executive officer.
  • Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies.

Four-Year Data Continue to Show Superior, Long-Term Survival Benefit with Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Thursday, September 17, 2020 - 11:15am

CR: As previously reported, 11% of patients who received Opdivo plus Yervoy achieved a CR, compared to 3% with sunitinib.

Key Points: 
  • CR: As previously reported, 11% of patients who received Opdivo plus Yervoy achieved a CR, compared to 3% with sunitinib.
  • CheckMate -214 is a Phase 3, randomized, open-label study evaluating the combination of Opdivo plus Yervoy versus sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
  • OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).
  • In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients.

New Data from Ciforadenant Phase 1b/2 Clinical Study Presented at ESMO Virtual Congress 2020

Thursday, September 17, 2020 - 8:01am

The data includes results from 15 patients treated in the combination arm and 14 patients treated in the control arm.

Key Points: 
  • The data includes results from 15 patients treated in the combination arm and 14 patients treated in the control arm.
  • The key data related to ciforadenant from the poster include:
    In the ciforadenant and atezolizumab combination arm (N=15), 11 patients had response assessment.
  • Corvus presented the latest data on RCC patients treated with ciforadenant , along with data supporting the Adenosine Gene Signatures ability to identify patients likely to respond to treatment with ciforadenant, at the ASCO20 Virtual Scientific Program in May 2020.
  • CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant and pembrolizumab.

NOXXON Presents Final Clinical Data From Phase 1/2 NOX-A12 / Keytruda® Combination Trial in Colorectal and Pancreatic Cancer at the ESMO Virtual Congress 2020

Thursday, September 17, 2020 - 8:00am

The patients in this study were, on average, receiving their 6th line of therapy in colorectal cancer and their 4th line of therapy in pancreatic cancer.

Key Points: 
  • The patients in this study were, on average, receiving their 6th line of therapy in colorectal cancer and their 4th line of therapy in pancreatic cancer.
  • As such, the data from this study provide signals that support a beneficial impact of the combination of NOX-A12 with pembrolizumab for patients with extremely limited options.
  • NOX-A12 penetrated cancer tissue in both pancreatic and colorectal cancer patients where it neutralized its target, CXCL12.
  • Building on extensive clinical experience and safety data, the lead program NOX-A12 has delivered top-line data from a Keytruda combination trial in metastatic colorectal and pancreatic cancer patients and further studies are being planned in these indications.

SpringWorks Therapeutics Announces Collaboration with Children’s Oncology Group to Conduct a Phase 2 Clinical Trial of Nirogacestat in Pediatric Patients with Desmoid Tumors and Reports Publication of Nirogacestat Case Series in Pediatric/Young Adult De

Wednesday, September 16, 2020 - 11:30am

These patients often require medical treatment and we look forward to working with SpringWorks to study nirogacestat in a pediatric population.

Key Points: 
  • These patients often require medical treatment and we look forward to working with SpringWorks to study nirogacestat in a pediatric population.
  • Following treatment with nirogacestat, the investigators reported a clinical response in all four patients.
  • These four patients had received between one and eight prior lines of therapy, including surgery, before being treated with nirogacestat.
  • The open-label, single arm Phase 2 study will evaluate the safety, pharmacokinetic and efficacy of nirogacestat in children and adolescents with progressive, surgically unresectable desmoid tumors.

DGAP-News: Positive Results from Adrenomed's AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented during e-ISICEM

Wednesday, September 16, 2020 - 7:00am

[1]

Key Points: 
  • [1]
    The AdrenOSS-2 Phase II trial ( NCT03085758 [2] ) achieved its primary endpoint: No differences in serious or possibly related Treatment Emergent Adverse Events (TEAEs) between Adrecizumab and placebo were observed.
  • As already demonstrated in previous Phase I trials, Adrecizumab exhibited a favorable safety and tolerability profile in septic shock patients.
  • [3]
    28-day all-cause mortality analysis including all patients (n=301) showed a trend towards a survival benefit for Adrecizumab treated patients.
  • Adrecizumab has successfully completed a biomarker-guided, double-blinded, placebo-controlled, randomized, multicenter proof-of-concept Phase II trial with 301 patients suffering from septic shock.

Translational Research in Oncology (TRIO) Enrolls First Patient in Early Breast Cancer Phase 2 Trial

Tuesday, September 15, 2020 - 2:00pm

EDMONTON, Alberta, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Translational Research in Oncology (TRIO), a global academic clinical research organization, announced today enrolment of the first patient in a Phase 2 randomized, multi-center, open-label clinical trial of GDC-9545 sponsored by F. Hoffmann-La Roche.

Key Points: 
  • EDMONTON, Alberta, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Translational Research in Oncology (TRIO), a global academic clinical research organization, announced today enrolment of the first patient in a Phase 2 randomized, multi-center, open-label clinical trial of GDC-9545 sponsored by F. Hoffmann-La Roche.
  • This current clinical trial will expand the safety and efficacy of GDC-9545 in combination with palbociclib into the early breast cancer setting.
  • Although we have effective therapies for hormone receptor positive breast cancer, disease resistance to these therapies occurs in some women, leading to the diagnosis of incurable breast cancer sometimes years later.
  • TRIO advances translational cancer research by introducing innovative and novel targeted therapeutic concepts into the clinical trial setting.

Gilead’s Magrolimab, an Investigational Anti-CD47 Monoclonal Antibody, Receives FDA Breakthrough Therapy Designation for Treatment of Myelodysplastic Syndrome

Tuesday, September 15, 2020 - 1:00pm

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS).

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly diagnosed myelodysplastic syndrome (MDS).
  • Breakthrough Therapy designation is designed to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions that, based on preliminary clinical evidence, have the potential to substantially improve clinical outcomes compared with available therapy.
  • The FDA granted Breakthrough Therapy designation for magrolimab based on positive results of an ongoing Phase 1b study, which evaluated magrolimab in combination with azacitidine in previously untreated intermediate, high and very high-risk MDS.
  • No maximum tolerated dose was reached and no MDS patients discontinued treatment due to a treatment-related adverse event.

European Medicines Agency Validates Bristol Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for First-line Treatment of Malignant Pleural Mesothelioma

Tuesday, September 15, 2020 - 11:59am

Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) validated a type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) validated a type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma (MPM).
  • By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
  • OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
  • In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients.