ECOG

New Post Hoc Analysis from MAVORIC Trial Sheds Light on Burden of Cutaneous T-cell Lymphoma on Health-related Quality of Life

Retrieved on: 
Monday, December 11, 2023

PRINCETON, N.J., Dec. 11, 2023 /PRNewswire/ -- Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company based in Japan, today announced health-related quality of life (HRQL) findings from a post hoc analysis of the MAVORIC trial in patients with mycosis fungoides (MF) or Sézary syndrome (SS), two subtypes of cutaneous T-cell lymphoma (CTCL). Researchers analyzed baseline data collected prior to initiation of study treatments and found the symptoms of advanced MF/SS affected HRQL across all domains, with poorer HRQL associated with being younger in age, female, having moderate or severe itching, and impaired function as measured by the Eastern Cooperative Oncology Group performance status (ECOG PS).

Key Points: 
  • Understanding how symptoms impact an individual physically, emotionally as well as in their daily life is critical," said Susan Thornton, Chief Executive Officer, Cutaneous Lymphoma Foundation and one of the study authors.
  • Bivariate analysis (t-tests and ANOVA) was used to identify demographic and medical history variables that had a relationship with HRQL.
  • LASSO (least absolute shrinkage and selection operator) regression analysis was used to identify factors that may drive poor HRQL.
  • Researchers concluded that assessing a patient's disease concerns may help guide treatment goals and therapeutic choice.

AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023

Retrieved on: 
Friday, December 8, 2023

THOUSAND OAKS, Calif., Dec. 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data from its blood cancer portfolio and pipeline at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place from Dec. 9-12 in San Diego.

Key Points: 
  • THOUSAND OAKS, Calif., Dec. 8, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data from its blood cancer portfolio and pipeline at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition, taking place from Dec. 9-12 in San Diego.
  • "Data at this year's ASH meeting illustrate the expanding potential of our innovative hematology medicines, BLINCYTO and KYPROLIS, as well as our commitment to providing additional treatment options with our biosimilar eculizumab," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "As the pioneer of T-cell engager technology and building on nearly a decade of real-world experience, we continue to advance our first-in-class BiTE® molecule, BLINCYTO, into earlier lines of treatment where we have seen encouraging data in patients living with acute lymphoblastic leukemia."
  • Preliminary Results of the Gimema ALLL2820 Trial
    Abstract # 4249 , Session #614, Monday, December 11 from 6:00 - 8:00 p.m. PT
    *E1910 is sponsored by National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by the NCI Funded National Clinical Trial Network.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

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Thursday, November 2, 2023

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.

Moleculin Presents Positive Preliminary Efficacy Findings from Phase 1B/2 Clinical Trial Demonstrating 64% Stable Disease Rate Through Two Cycles of Annamycin for the Treatment of Soft Tissue Sarcomas (STS) Lung Metastases

Retrieved on: 
Monday, November 6, 2023

HOUSTON, Nov. 6, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses, today announced the presentation of preliminary efficacy findings from the Phase 2 portion of the Company's ongoing U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).

Key Points: 
  • Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).
  • We look forward to further data readouts from this trial and understanding the full potential of Annamycin for the treatment of STS lung mets."
  • The other subject maintained SD through 8 cycles prior to progressing ~6.9 months after initiating treatment with Annamycin.
  • Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107) visit clinicaltrials.gov and reference identified NCT04887298.

Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study

Retrieved on: 
Monday, October 23, 2023

SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY), (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

Key Points: 
  • These data demonstrated a 40% overall disease control rate and provided further encouraging data for pelareorep," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.
  • Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab.
  • GOBLET Study 3L Metastatic CRC Patient Overview:
    Patients in the CRC cohort, presented at ESMO 2023, are undergoing third-line treatment with a combination of pelareorep, atezolizumab, and trifluridine/tipiracil.
  • The enrolled patient population included patients with an ECOG score of ≤1 and confirmed colorectal cancer, regardless of microsatellite instability status.

Oncolytics Achieves Success Criteria for Efficacy in the Third-Line Colorectal Cancer Cohort of the GOBLET Study

Retrieved on: 
Monday, October 23, 2023

SAN DIEGO and CALGARY, AB, Oct. 23, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY), (Oncolytics) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced the poster presentation of interim results from the Phase 1/2 GOBLET study evaluating a combination treatment of pelareorep in patients with third-line (3L) metastatic colorectal cancer (CRC) regardless of microsatellite instability status at the European Society for Medical Oncology meeting (ESMO 2023), taking place in Madrid, Spain.

Key Points: 
  • These data demonstrated a 40% overall disease control rate and provided further encouraging data for pelareorep," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics.
  • Notably, this is the second GOBLET study cohort in a row that has met its success criteria, further supporting pelareorep's ability to synergize with atezolizumab.
  • GOBLET Study 3L Metastatic CRC Patient Overview:
    Patients in the CRC cohort, presented at ESMO 2023, are undergoing third-line treatment with a combination of pelareorep, atezolizumab, and trifluridine/tipiracil.
  • The enrolled patient population included patients with an ECOG score of ≤1 and confirmed colorectal cancer, regardless of microsatellite instability status.

Moleculin Announces Completion of Enrollment in U.S. Phase 1B/2 Clinical Trial Evaluating Annamycin for the Treatment of Soft Tissue Sarcoma Lung Metastases (MB107)

Retrieved on: 
Thursday, September 21, 2023

HOUSTON, Sept. 21, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat cancers and viruses, today announced the completion of enrollment in the Phase 2 portion of the Company's U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107). Subjects who had stable disease at time of study discontinuation will continue to be followed for progression free response and overall survival.

Key Points: 
  • Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107).
  • Subjects who had stable disease at time of study discontinuation will continue to be followed for progression free response and overall survival.
  • "The completion of enrollment for our MB107 study marks an important milestone for our STS clinical development program.
  • Phase 1B/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma lung metastases (MB107) visit clinicaltrials.gov and reference identified NCT04887298.

OSE Immunotherapeutics Announces: Positive Phase 3 Data from its Cancer Vaccine in Lung Cancer Patients with Resistance to Previous Immunotherapy Published in Annals of Oncology

Retrieved on: 
Monday, September 11, 2023

Tedopi® is a novel T-cell epitope-based cancer vaccine targeting five tumor-associated antigens, an activating and differentiated off-the-shelf immunotherapy expanding tumor specific T-lymphocytes in HLA-A2 cancer patients.

Key Points: 
  • Tedopi® is a novel T-cell epitope-based cancer vaccine targeting five tumor-associated antigens, an activating and differentiated off-the-shelf immunotherapy expanding tumor specific T-lymphocytes in HLA-A2 cancer patients.
  • A significant reduction of the risk of death by 41% was achieved with a better safety profile and a maintained quality of life.
  • This study, conducted in patients with secondary resistance to immunotherapy, compared Tedopi® monotherapy with standard of care docetaxel or pemetrexed chemotherapies.
  • It is subdivided into 5 grades from 0 to 5, ranging from fully active (0) to fully disabled, then to death (5).

Surgical Outcomes of Perioperative Durvalumab in AEGEAN Study to be Presented at IASLC 2023 World Conference on Lung Cancer

Retrieved on: 
Tuesday, September 12, 2023

SINGAPORE, Sept. 12, 2023 /PRNewswire-PRWeb/ -- Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.

Key Points: 
  • Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.
  • SINGAPORE, Sept. 12, 2023 /PRNewswire-PRWeb/ -- Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.
  • The AEGEAN trial is a double-blind, placebo-controlled phase 3 study that evaluated the use of perioperative durvalumab in combination with neoadjuvant chemotherapy compared to neoadjuvant chemotherapy alone.
  • AEGEAN data from outcomes for patients with documented EGFR mutations are also being presented at IASLC 2023 World Conference on Lung Cancer.

Six-Year Follow-Up Data on CheckMate 227 Survival and Quality of Life Benefits Unveiled for Patients with Metastatic NSCLC and Nivolumab + Ipilimumab Treatment

Retrieved on: 
Sunday, September 10, 2023

Research findings from the CheckMate 227 trial will be presented, shedding light on the extraordinary six-year survival and quality of life benefits associated with first-line nivolumab plus ipilimumab therapy.

Key Points: 
  • Research findings from the CheckMate 227 trial will be presented, shedding light on the extraordinary six-year survival and quality of life benefits associated with first-line nivolumab plus ipilimumab therapy.
  • "The evidence we present offers a compelling case for the transformative potential of nivolumab + ipilimumab in metastatic NSCLC treatment.
  • Patients were divided into different cohorts based on tumor PD-L1 expression levels and randomized to receive nivolumab plus ipilimumab, nivolumab, nivolumab plus chemotherapy or chemotherapy alone.
  • "The evidence we present offers a compelling case for the transformative potential of nivolumab plus ipilimumab in metastatic NSCLC treatment.