Chemotherapy regimen

Moleculin Receives Approval to Extend Dose Escalation in Phase 1/2 European Clinical Trial Evaluating Annamycin for the Treatment of Acute Myeloid Leukemia

Retrieved on: 
Tuesday, July 13, 2021

Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.

Key Points: 
  • Annamycin is the Company's next-generation anthracycline that has demonstrated a lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML.
  • Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin.
  • This amendment will allow us to continue dose escalation in the Phase 1 portion of the trial and establish the maximum tolerated dose as we work toward the recommended dose for the Phase 2 portion of the study.
  • Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.

Non-Hodgkin Lymphoma Pipeline Therapeutics Report, H2 2020 Review Featuring 450+ Companies & Respective Drug Profiles - ResearchAndMarkets.com

Retrieved on: 
Friday, April 2, 2021

Non-Hodgkin Lymphoma - Pipeline Review, H2 2020, provides an overview of the Non-Hodgkin Lymphoma (Oncology) pipeline landscape.

Key Points: 
  • Non-Hodgkin Lymphoma - Pipeline Review, H2 2020, provides an overview of the Non-Hodgkin Lymphoma (Oncology) pipeline landscape.
  • Non-Hodgkin Lymphoma - Pipeline Review, H2 2020, provides comprehensive information on the therapeutics under development for Non-Hodgkin Lymphoma (Oncology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type.
  • The pipeline guide reviews pipeline therapeutics for Non-Hodgkin Lymphoma (Oncology) by companies and universities/research institutes based on information derived from company and industry-specific sources.
  • The pipeline guide reviews key companies involved in Non-Hodgkin Lymphoma (Oncology) therapeutics and enlists all their major and minor projects.

FDA approves Sarclisa® (isatuximab-irfc) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma

Retrieved on: 
Wednesday, March 31, 2021

"This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma."

Key Points: 
  • "This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma."
  • "Treatment of patients with relapsed or refractory multiple myeloma remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor," said Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi.
  • The median progression free survival (PFS) for Sarclisa combination therapy was not reached at the time of the pre-planned interim analysis.
  • The rate of CR was 39.7% in the Sarclisa combination therapy arm and 27.6% in the Kd arm.

FDA approves Sarclisa® (isatuximab) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma

Retrieved on: 
Wednesday, March 31, 2021

This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma.

Key Points: 
  • This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma.
  • Treatment of patients with relapsed or refractory multiple myeloma remains challenging and the prognosis for patients experiencing multiple relapses unfortunately is poor, said Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi.
  • With this approval, Sarclisa is now included in two standard of care regimens for the treatment of patients with multiple myeloma as early as first relapse.
  • Todays milestone further supports our ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma.

Provectus Biopharmaceuticals Announces Release of Preprint Manuscript Describing Preclinical Study of PV-10® Immunotherapy and Chemotherapy for Treatment of Pancreatic Cancer

Retrieved on: 
Wednesday, January 20, 2021

Chemotherapy regimens that include gemcitabine are the standard of care for the treatment of pancreatic cancer.

Key Points: 
  • Chemotherapy regimens that include gemcitabine are the standard of care for the treatment of pancreatic cancer.
  • The manuscript, entitled Intralesional injection of Rose Bengal augments the efficacy of gemcitabine chemotherapy against pancreatic tumors, is available at the following link: https://assets.researchsquare.com/files/rs-140621/v1/cb1df721-b58b-4f5d-... .
  • PV-10 treatment-mediated DAMP-release has been demonstrated in three different tumor types: melanoma, colon cancer, and now pancreatic cancer.
  • This suggested that increased pancreatic tumor burden, which diminished gemcitabine efficacy, was overcome when PV-10 was combined with gemcitabine.

ALX Oncology Announces New Data from ASPEN-01, the Phase 1b Study of ALX148, Showing Promising Initial Clinical Responses in Patients with Advanced Solid Tumors

Retrieved on: 
Monday, November 9, 2020

Updated data from patients with >2L HER2 positive GC receiving ALX148 plus trastuzumab suggests promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.

Key Points: 
  • Updated data from patients with >2L HER2 positive GC receiving ALX148 plus trastuzumab suggests promising clinical activity after their tumors have progressed upon prior trastuzumab therapy.
  • Preliminary data suggests that ALX148 can be safely combined with multi-agent chemotherapy regimens studied with no maximum tolerated dose reached.
  • ALX148 has demonstrated promising clinical responses across a range of hematologic and solid malignancies in combination with a number of leading anti-cancer agents.
  • ALX Oncology intends to continue clinical development of ALX148 for the treatment of a range of solid tumor indications and myelodysplastic syndromes.

American Society of Hematology (ASH) Abstract Shows Initial Anti-Leukemic Activity of UCART22 in BALLI-01 Phase 1 Study in R/R Adult B-ALL

Retrieved on: 
Wednesday, November 4, 2020

This will be the first publicly released data from Cellectis Phase 1 dose-escalation study of UCART22 product candidate in adult patients with Relapsed/Refractory CD22+ B-ALL.

Key Points: 
  • This will be the first publicly released data from Cellectis Phase 1 dose-escalation study of UCART22 product candidate in adult patients with Relapsed/Refractory CD22+ B-ALL.
  • BALLI-01 is a Phase 1 open-label dose-escalation study designed to assess the safety, the maximum tolerated dose (MTD), and preliminary anti-leukemia activity of UCART22 in patients with R/R B-ALL.
  • The abstract includes preliminary data from the first five patients who received escalating doses of UCART22 cells after fludarabine/cyclophosphamide (FC) lymphodepletion.
  • UCART22 demonstrated preliminary signs of activity at low dose levels with fludarabine/cyclophosphamide (FC) lymphodepletion regimen, without unexpected nor significant treatment-related toxicities.

FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional

Retrieved on: 
Monday, June 29, 2020

HER2-positive breast cancer, which makes up approximately one-fifth of breast cancers, has too much of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.

Key Points: 
  • HER2-positive breast cancer, which makes up approximately one-fifth of breast cancers, has too much of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.
  • Phesgo is initially used in combination with chemotherapy and could continue to be administered at home by a qualified health care professional once the chemotherapy regimen is finished.
  • "Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers.
  • Health care professionals should use similar monitoring parameters as those used with IV pertuzumab and IV trastuzumab.

Karyopharm Announces FDA Approval of XPOVIO® (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Monday, June 22, 2020

The clinical profile and tolerability of oral XPOVIO provides physicians and patients with a new treatment alternative to traditional intravenous chemotherapy regimens.

Key Points: 
  • The clinical profile and tolerability of oral XPOVIO provides physicians and patients with a new treatment alternative to traditional intravenous chemotherapy regimens.
  • Karyopharm will host a conference call today, Monday, June 22, 2020, at 12:30 p.m. Eastern Time, to discuss the FDAs approval of XPOVIO for the treatment of patients with relapsed or refractory DLBCL.
  • In June 2020, XPOVIO was approved by the FDA as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma.
  • Such forward-looking statements include those regarding Karyopharms beliefs regarding XPOVIOs ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma and expectations related to other XPOVIO regulatory submissions.

New Phase II data indicate regimen of Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in relapsed/refractory aggressive B-cell lymphoma

Retrieved on: 
Monday, June 15, 2020

3 patients experienced higher than grade 2 toxicity and the most common adverse event regardless of grade was skin toxicity, observed in 4 patients.

Key Points: 
  • 3 patients experienced higher than grade 2 toxicity and the most common adverse event regardless of grade was skin toxicity, observed in 4 patients.
  • By incorporating biosimilar rituximab into combination therapies alongside new drugs, the overall cost burden can be reduced, enhancing patient access.
  • DLBCL is an aggressive condition and it is common to find patients with advanced disease at the point of diagnosis.
  • Rituximab, lenalidomide and acalabrutinib (R2A) for relapsed/refractory aggressive B-cell lymphoma: Interim analysis reporting good tolerability and potential durable response.