RECIST

Ongoing Results From a Dose Expansion Cohort of CYT-0851 in Combination With Capecitabine in Advanced Platinum-Resistant Ovarian Cancer Show Promising Clinical Activity and Generally Well Tolerated Safety Profile

Retrieved on: 
Thursday, October 12, 2023
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Other secondary objectives included the determination of pharmacokinetic parameters and to characterize the preliminary anti-tumor activity.

Key Points: 
  • Other secondary objectives included the determination of pharmacokinetic parameters and to characterize the preliminary anti-tumor activity.
  • The poster presents ongoing results for eleven evaluable patients with platinum-refractory or -resistant ovarian cancer treated in this expansion cohort.
  • As of the September 26, 2023 data cutoff, 11 patients with advanced ovarian cancer were treated and evaluable in the capecitabine cohort.
  • To date, CYT-0851 has exhibited a generally well tolerated safety profile with no unanticipated toxicities observed at clinically active doses.

New FDA Designations Accelerate Progress in Pancreatic Cancer Treatments: A Year in Review

Retrieved on: 
Friday, October 13, 2023
MBA, NYSE, Colorectal cancer, RET, Safety, US Foods, Therapy, Oncolytics Biotech, Breakthrough therapy, Transfection, News, NRG1, Research, Eli Lilly and Company, Cancer, HIV disease progression rates, Gastrointestinal cancer, JD, MD Anderson Cancer Center, AstraZeneca, LLY, EDB, Spacecraft, TSX, Eye, Pyxis, Liver, Disease, System, FDA, RECIST, University, Pancreatic Cancer Action Network, Thorax, Immunotherapy, FTD, Extracellular matrix, Fusion, Neoplasm, Congress, GI, Incidence, ORR, MD, ONC, Meru Networks, Colon, AZN, Pancreatic cancer, Patient, BTC, Johns Hopkins University, Pharmaceutical industry, Durvalumab, Lancet

VANCOUVER, BC, Oct. 13, 2023 /PRNewswire/ -- USA News Group  -  Since September 2022, the US Food and Drug Administration (FDA) has seen new treatments for pancreatic cancer that are worthy of further investigation or approval. Known as one of the deadliest cancers on earth, analysis published in The Lancet in April 2023 showed a rising incidence of pancreatic cancer among individuals younger than 55 years, further demonstrating a need for more treatments. Among the treatments in development that caught the eye of the FDA over the past year are those that have come from  Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Pyxis Oncology, Inc. (NASDAQ: PYXS), AstraZeneca PLC (NASDAQ: AZN), Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS).

Key Points: 
  • A lot of the main efforts in fighting this particular cancer are in line with the work of the Pancreatic Cancer Action Network (PanCAN).
  • They've been asking supporters from every state in the US to get in touch with Congress to boost federal funds for pancreatic cancer research.
  • Near the end of 2022, the FDA rewarded pelareorep with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • Out of the 13 patients checked, one had a complete response - something that doesn't happen often when treating pancreatic cancer.

New FDA Designations Accelerate Progress in Pancreatic Cancer Treatments: A Year in Review

Retrieved on: 
Friday, October 13, 2023
MBA, NYSE, Colorectal cancer, RET, Safety, US Foods, Therapy, Oncolytics Biotech, Breakthrough therapy, Transfection, News, NRG1, Research, Eli Lilly and Company, Cancer, HIV disease progression rates, Gastrointestinal cancer, JD, MD Anderson Cancer Center, AstraZeneca, LLY, EDB, Spacecraft, TSX, Eye, Pyxis, Liver, Disease, System, FDA, RECIST, University, Pancreatic Cancer Action Network, Thorax, Immunotherapy, FTD, Extracellular matrix, Fusion, Neoplasm, Congress, GI, Incidence, ORR, MD, ONC, Meru Networks, Colon, AZN, Pancreatic cancer, Patient, BTC, Johns Hopkins University, Pharmaceutical industry, Durvalumab, Lancet

VANCOUVER, BC, Oct. 13, 2023 /PRNewswire/ -- USA News Group  -  Since September 2022, the US Food and Drug Administration (FDA) has seen new treatments for pancreatic cancer that are worthy of further investigation or approval. Known as one of the deadliest cancers on earth, analysis published in The Lancet in April 2023 showed a rising incidence of pancreatic cancer among individuals younger than 55 years, further demonstrating a need for more treatments. Among the treatments in development that caught the eye of the FDA over the past year are those that have come from  Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Pyxis Oncology, Inc. (NASDAQ: PYXS), AstraZeneca PLC (NASDAQ: AZN), Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS).

Key Points: 
  • A lot of the main efforts in fighting this particular cancer are in line with the work of the Pancreatic Cancer Action Network (PanCAN).
  • They've been asking supporters from every state in the US to get in touch with Congress to boost federal funds for pancreatic cancer research.
  • Near the end of 2022, the FDA rewarded pelareorep with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • Out of the 13 patients checked, one had a complete response - something that doesn't happen often when treating pancreatic cancer.

Nuvalent Reports Preliminary Phase 1 Clinical Data from ALKOVE-1 Trial that Support Best-In-Class Potential of NVL-655 for Patients with ALK-Positive NSCLC

Retrieved on: 
Friday, October 13, 2023
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CAMBRIDGE, Mass., Oct. 13, 2023 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced updated preliminary data from the Phase 1 dose-escalation portion of its ongoing ALKOVE-1 Phase 1/2 clinical trial of NVL-655 for patients with advanced ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. These data will be presented today at the 35th AACR-NCI-EORTC (ANE) Symposium in Boston, Massachusetts.

Key Points: 
  • Preliminary activity data as of the cut-off date were available from 51 heavily pre-treated response-evaluable NSCLC patients.
  • In the subset of 41 patients treated at dose levels of 50 mg QD or higher, the ORR was 44% (18/41).
  • The Phase 2 cohorts are intended to support potential registration in patients with ALK-positive NSCLC who are both lorlatinib-naïve and lorlatinib-treated.
  • In addition to the planned Phase 2 cohorts, Nuvalent intends to use these preliminary data in patients with heavily pre-treated ALK-positive NSCLC to guide discussions with physicians that will inform development strategies in TKI-naïve ALK-positive NSCLC.

Nanobiotix Announces the Presentation of the Final Efficacy Analysis From Phase 1 Cohort Expansion Evaluating NBTXR3 in Locally Advanced Head and Neck Cancer Showing Median Progression-Free Survival of 16.9 Months and Median Overall Survival of 23.1 Month

Retrieved on: 
Wednesday, October 4, 2023
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During the call, Laurent Levy, chief executive officer, will review the Study 102 final data before taking questions from participants.

Key Points: 
  • During the call, Laurent Levy, chief executive officer, will review the Study 102 final data before taking questions from participants.
  • Surgery or definitive cisplatin-based chemotherapy are the current standard of care for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC; head and neck cancer).
  • One third of these patients, however, cannot tolerate cisplatin due to complications such as age-related frailty or other medical conditions (comorbidities).
  • At the final readout, an independent review committee determined a median Progression-Free Survival (mPFS) of 16.9 months in evaluable patients.

Purple Biotech Reports Positive Interim and Preliminary Results from NT219 Phase 1/2 Study in R/M Head & Neck Cancer

Retrieved on: 
Tuesday, October 3, 2023
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No dose-limiting toxicities (DLTs) were reported in either cohort and NT219 was well tolerated as a monotherapy and in combination with cetuximab.

Key Points: 
  • No dose-limiting toxicities (DLTs) were reported in either cohort and NT219 was well tolerated as a monotherapy and in combination with cetuximab.
  • Other results from the Phase 1/2 study will be provided at one of the upcoming medical conferences.
  • The Company is in the process of designing a Phase 2 study of NT219 in combination with cetuximab in 2L R/M SCCHN.
  • Gil Efron, Purple Biotech CEO, added, “I am very satisfied with the observed activity of NT219 in recurrent and/or metastatic SCCHN patients.

Advances in oncological imaging: Tumour growth rate modelling and radiomics, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Thursday, September 28, 2023
Medical imaging, Neoplasm, Clutch (eggs), Radiomics, Survival, Clinical trial, RECIST, ICON, AI, TGR, Doctor of Philosophy, Biomarker, G, Medical device

TORONTO, Sept. 28, 2023 /PRNewswire-PRWeb/ -- The use of medical imaging biomarkers to better understand the efficacy of cancer drugs, aided by the power of AI.

Key Points: 
  • Attendees will learn about various models for the estimation of tumour growth rate ('g'), including exponential models.
  • Growth rate ('g') of tumour derived by appropriate tumour growth rate (TGR) modelling, as well as quantitative estimation of tumour heterogeneity through radiomics are two processes that offer such oncological imaging biomarkers.
  • In this webinar, we will discuss the basics of TGR modelling from oncological imaging data, as well as radiomics.
  • For more information, or to register for this event, visit Advances in oncological imaging: Tumour growth rate modelling and radiomics .

PADCEV® (enfortumab vedotin-ejfv) and KEYTRUDA® (pembrolizumab) Significantly Improve Overall Survival and Progression-Free Survival in Patients With Previously Untreated Advanced Bladder Cancer in Pivotal Phase 3 EV-302 Trial

Retrieved on: 
Friday, September 22, 2023
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The EV-302 trial enrolled patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.

Key Points: 
  • The EV-302 trial enrolled patients with previously untreated la/mUC who were eligible for cisplatin- or carboplatin-containing chemotherapy regardless of PD-L1 status.
  • View the full release here: https://www.businesswire.com/news/home/20230922521064/en/
    The EV-302 study met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), compared to chemotherapy.
  • The safety results of the combination are consistent with those of enfortumab vedotin in combination with pembrolizumab previously reported in cisplatin-ineligible patients with la/mUC.
  • The trial is part of an extensive program evaluating this combination in multiple stages of urothelial cancer.

BioLineRx Announces Acceptance of Oral Presentation on Pilot Phase Data from Phase 2 Combination Clinical Trial with Motixafortide in First-Line PDAC at AACR Special Conference on Pancreatic Cancer

Retrieved on: 
Tuesday, September 19, 2023
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TEL AVIV, Israel, Sept. 19, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that pilot phase data from an investigator-initiated, open-label, multicenter Phase 2 clinical trial with motixafortide in first-line pancreatic ductal adenocarcinoma (PDAC) will be presented at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer taking place in Boston, Massachusetts, September 27-30, 2023. The Phase 2 clinical trial is designed to evaluate the company's CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).

Key Points: 
  • The Phase 2 clinical trial is designed to evaluate the company's CXCR4 inhibitor motixafortide in combination with PD-1 inhibitor cemiplimab and standard of care chemotherapies gemcitabine and nab-paclitaxel, versus gemcitabine and nab-paclitaxel alone, in first-line pancreatic cancer (PDAC).
  • Sponsored by Columbia University, the single-arm pilot phase of the Phase 2 trial focused on the safety of the drug combination.
  • Earlier this year, following a review of the pilot phase data, the trial was amended to become a randomized study, with planned enrollment increasing from 30 to 102 patients.
  • Presentation at AACR Special Conference in Cancer Research: Pancreatic Cancer
    Presenter: Gulam A. Manji, MD, PhD, Columbia University Irving Medical Center/New York Presbyterian, New York, N.Y.

A Phase 2 Study of Anti-Siglec-15 Antibody, NC318, in Combination with Pembrolizumab (NCT04699123) Demonstrates Clinical Activity in Patients with Advanced PD-1 Axis Inhibitor Refractory NSCLC

Retrieved on: 
Tuesday, September 12, 2023
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BELTSVILLE, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the presentation of Phase 2 clinical data by collaborators at the Yale Cancer Center demonstrating clinical benefit in patients with advanced, PD-1 axis inhibitor refractory non-small cell lung cancer (NSCLC) treated with a combination regimen of NC318, a Siglec-15 (S15) monoclonal antibody (mAb), and pembrolizumab, an anti-PD-1 antibody.

Key Points: 
  • In an earlier monotherapy study from NextCure, NC318 demonstrated single agent activity in a Phase 1/2 dose escalation trial (NCT03665285) for patients with advanced solid tumors (Tolcher et al, SITC 2019).
  • The ongoing NCT04699123 study is a randomized trial designed to assess the safety and efficacy of NC318 alone or in combination with pembrolizumab.
  • The combination portion of the study is assessing efficacy in NSCLC subjects who have experienced disease progression on, or after, PD-1 axis inhibitor therapy.
  • NC318 infusion reactions were seen in seven patients (three Grade 3, four Grade 2), six receiving the combination and one NC318 alone.