DOR

Analyses of Kite’s Yescarta® CAR T-Cell Therapy Support Curative Potential in Patients With Non-Hodgkin Lymphomas

Retrieved on: 
Tuesday, December 12, 2023
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In this post hoc analysis of ZUMA-1, with up to six years of follow-up, the five-year long-term lymphoma-related event-free survival (LREFS) was used as a measure to explore Yescarta’s curative potential.

Key Points: 
  • In this post hoc analysis of ZUMA-1, with up to six years of follow-up, the five-year long-term lymphoma-related event-free survival (LREFS) was used as a measure to explore Yescarta’s curative potential.
  • Yescarta had long-term LREFS in a substantial proportion of patients, with a five-year rate of 34% (57% among patients who achieved a CR).
  • Among patients who had a CR to therapy, the leading risks of death were reasons other than progression or adverse events after month 24 post-infusion.
  • “We are encouraged by these data, particularly the continued durable response and long-term survival in these patient populations that speak to the potentially curative benefit of this therapy.

Long-Term Data for Kite’s Yescarta® CAR T-Cell Therapy Presented at ASH 2023 Demonstrate High Rate of Durable Response in Patients With High-Risk Large B-Cell Lymphoma

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, BCL2, Fever, MYC, Progression-free survival, ASH, Aes, CRS, EFS, B-cell lymphoma, Headache, Cytopenia, Non-Hodgkin lymphoma, Patient, Abstract, PFS, DOR, BCL6, Histology, ORR, MD, Survival, Doctor of Philosophy, Drug, Society, OS, Confidence interval, Axicabtagene ciloleucel, SVP, Cytokine release syndrome, Pharmaceutical industry

“Patients with high-risk, large B-cell lymphoma, have a poor prognosis with currently available therapies,” said Julio C. Chavez, MD, lead investigator, Moffitt Cancer Center.

Key Points: 
  • “Patients with high-risk, large B-cell lymphoma, have a poor prognosis with currently available therapies,” said Julio C. Chavez, MD, lead investigator, Moffitt Cancer Center.
  • “This is particularly true of patients with double- or triple-hit histology, who have a median survival of under a year with standard treatment.
  • Prolonged cytopenias of any grade (present Day ≥30 post-infusion) occurred in 9 patients (n=7 neutrophil count decreased) and were resolved by data cutoff.
  • Among treated patients, the in vivo Yescarta expansion and persistence profiles are consistent with previous observations.

Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Paclitaxel, Tamoxifen, CDK, Food, Letrozole, Carcinoma, Fulvestrant, Progression-free survival, Doctor of Pharmacy, Breast cancer, Patient, Anastrozole, PFS, BID, FDA, Puma Biotechnology, DOR, DCR, ORR, PUMA, Phase, Biomarker, Cancer, Pharmaceutical industry, Birth control

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).

Key Points: 
  • Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201).
  • The Company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers.
  • “There continues to be a need for new drugs for the treatment of metastatic HER2-negative, hormone receptor-positive breast cancer,” said Alvin Wong, PharmD, Chief Scientific Officer of Puma Biotechnology.
  • “The clinical trials of alisertib to date in HER2-negative, hormone receptor-positive metastatic breast cancer have demonstrated alisertib’s potential clinical benefit in this patient population, and we look forward to initiating the PUMA-ALI-1201 trial in 2024.”
    Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are excited to move forward with the development of alisertib in HER2-negative hormone receptor-positive metastatic breast cancer.

Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs

Retrieved on: 
Tuesday, December 12, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Dexamethasone, ASH, CRS, Patient, Cell, Infection, Bortezomib, B-cell maturation antigen, GPRC5D, Carfilzomib, Therapy, Bristol Myers Squibb, ORR, Cancer, Diagnosis, Anemia, International Myeloma Foundation, CD3, Cytokine release syndrome, Haematopoietic system, Multiple myeloma, Immunomodulatory imide drug, Safety, Immune system, Incidence, Aes, DOR, Science, Hook effect, Public, Drug discovery, Society, Estate (law), Lenalidomide, Proteasome inhibitor, Thrombocytopenia, PFS, BMY, Daratumumab, Neutropenia, Partnership, Skin, Life, Mezi proudy, Research, NYSE, Disease, MRD, Translational Genomics Research Institute, TCE, Survival, BMS, BCMA, Biology, Pharmaceutical industry, Vaccine, Fine chemical, Cohort, RRMM

Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced updated results from three key programs within its broad multiple myeloma research pipeline, highlighting its diverse targets and molecular approaches to address unique patient needs within the disease.
  • These data were presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, California.
  • While multiple myeloma remains a relentless disease, we continue to transform the multiple myeloma treatment paradigm by dramatically improving outcomes for every patient.
  • As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 100% Progression Free Survival at 12 months in Phase 2 Trial of Patients with Early Stage Classical Hodgkin Lymphoma

Retrieved on: 
Monday, December 11, 2023
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This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.

Key Points: 
  • This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.
  • The PFS rate was 100% (95% CI: 100, 100) at 12 months and 97% (95% CI: 90.3, 99.1) at 18 months.
  • Among 56 efficacy-evaluable patients, 95% had an OR (95% CI: 85.1, 98.9) and 89% had a CR (95% CI: 78.1, 96.0).
  • The estimated PFS rate at 24 months was 88% (95% CI: 75.7, 94.6), with a median follow-up of 24.2 months (95% CI: 23.4, 26.9).

Latest Data of InnoCare’s Oncology Pipelines Presented at the 65th Annual Meeting of ASH

Retrieved on: 
Monday, December 11, 2023
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InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the latest data from InnoCare’s oncology studies were presented at the 65th American Society of Hematology (ASH) Annual Meeting.
  • The study of orelabrutinib’s regimen in patients with untreated mantle cell lymphoma (MCL) was selected as an oral presentation.
  • The overall response rate (ORR) was 100%, and the complete response rate (CRR) was 76.2%.
  • This retrospective data suggests that orelabrutinib in combination with rituximab has an encouraging anti-tumor activity in MZL, with a favorable safety profile.

Bristol Myers Squibb Presents New Data at ASH 2023 Demonstrating Clinical Benefit Across B-cell Malignancies with Breyanzi as a Second-Line Treatment in High-Risk Follicular Lymphoma and in Relapsed or Refractory Chronic Lymphocytic Leukemia

Retrieved on: 
Monday, December 11, 2023
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TRANSCEND FL is the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL.

Key Points: 
  • TRANSCEND FL is the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL.
  • Additionally, the company presented long-term data from the TRANSCEND CLL 004 study evaluating Breyanzi in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) with 24-month follow-up ( Oral Presentation #330 ).
  • Bristol Myers Squibb (BMS) has the broadest ongoing cell therapy development program in CD19-positive malignancies with Breyanzi, which also includes trials investigating its use in patients with relapsed/refractory mantle cell lymphoma (MCL).
  • In the TRANSCEND FL clinical trial, 130 patients with relapsed or refractory follicular lymphoma (FL) were enrolled and treated with Breyanzi in the second-line and third-line plus settings.

Merck Announces Findings from Phase 2 KeyVibe-002 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, December 7, 2023
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Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).

Key Points: 
  • Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).
  • Vibostolimab/pembrolizumab plus docetaxel improved OS compared with docetaxel alone, though these results did not reach statistical significance (HR=0.76 [95% CI, 0.50-1.15]).
  • The safety profile of vibostolimab/pembrolizumab was consistent with that observed for vibostolimab and pembrolizumab in previously reported studies, with no new safety signals observed.
  • Ongoing Phase 3 studies in lung cancer include KeyVibe-003 , KeyVibe-006 , KeyVibe-007 and KeyVibe-008 , as well as KeyVibe-010 in melanoma.

BeiGene Receives European Commission Approval for BRUKINSA® (zanubrutinib) for the Treatment of Relapsed or Refractory Follicular Lymphoma

Retrieved on: 
Friday, November 17, 2023
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“With this approval, we are excited to announce that BRUKINSA will become available as a treatment option for patients with follicular lymphoma in the European Union.

Key Points: 
  • “With this approval, we are excited to announce that BRUKINSA will become available as a treatment option for patients with follicular lymphoma in the European Union.
  • Responses were durable with 18-month landmark duration of response (DOR) of 69.3% in the BRUKINSA combination arm.
  • BRUKINSA plus obinutuzumab was generally well-tolerated, with safety results consistent with previous studies of both medicines.
  • “The results from the ROSEWOOD trial demonstrated a significant clinical benefit of BRUKINSA plus obinutuzumab for patients with relapsed or refractory follicular lymphoma.

FORE Biotherapeutics Announces Oral Presentation at SNO 2023 Reporting Updated Phase 1/2a Results for Plixorafenib in BRAF V600 Advanced Solid Tumors, Including Novel Data for Patients with BRAF V600 Primary CNS Tumors

Retrieved on: 
Friday, November 17, 2023
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FORE Biotherapeutics today reported updated safety and efficacy data from the Phase 1/2a clinical trial evaluating plixorafenib (FORE8394; PLX8394), a novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations.

Key Points: 
  • FORE Biotherapeutics today reported updated safety and efficacy data from the Phase 1/2a clinical trial evaluating plixorafenib (FORE8394; PLX8394), a novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations.
  • The results continue to demonstrate promising single-agent activity against BRAF V600-mutated tumors, including primary central nervous system tumors (PCNSTs), as presented at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting, being held November 15-19, 2023, in Vancouver, Canada.
  • “The updated data from our Phase 1/2a study continues to reinforce plixorafenib’s differentiated clinical profile in patients harboring BRAF V600 mutations,” said Stacie Shepherd, MD, PhD, and Chief Medical Officer of FORE.
  • “The data presented today at SNO 2023 demonstrate deep and durable confirmed responses in MAPK inhibitor-naïve patients, including a 67% overall response rate in patients with primary central nervous system tumors.