Treatment of lung cancer

Dizal Demonstrates Clinical Update for Sunvozertinib (DZD9008) in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 WCLC

Retrieved on: 
Friday, August 5, 2022
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Sunvozertinib, which was granted Breakthrough Therapy Designation by US FDA and China NMPA, is a rationally designed, oral, potent EGFR Exon20ins inhibitor, with wild-type EGFR selectivity.

Key Points: 
  • Sunvozertinib, which was granted Breakthrough Therapy Designation by US FDA and China NMPA, is a rationally designed, oral, potent EGFR Exon20ins inhibitor, with wild-type EGFR selectivity.
  • Updated findings from the studies were presented at 2022 WCLC.
  • As of April 30, 2022, in platinum-pretreated patients (n=119), the best ORR (at the RP2D of 300mg QD) assessment according to RECIST guidelines (version 1.1) was 52.4%.
  • In patients with baseline brain metastasis, the best ORR at 300 mg QD reached 44%.

Dizal Demonstrates Clinical Update for Sunvozertinib (DZD9008) in Platinum-Pretreated NSCLC Patients with EGFR Exon20ins Mutations at 2022 WCLC

Retrieved on: 
Friday, August 5, 2022
Social conditioning, Lung cancer, RECIST, CEO, Diagnosis, Cancer, Research, Breakthrough therapy, Environment, Rash, US FDA, NSCLC, Patient, Epidemiology, EGFR, Director, WCLC, Therapy, Nature, International Association, Treatment of lung cancer, News, Mutation, US, Conference, Diarrhea, Health, Uranium, Pharmaceutical industry

Sunvozertinib, which was granted Breakthrough Therapy Designation by US FDA and China NMPA, is a rationally designed, oral, potent EGFR Exon20ins inhibitor, with wild-type EGFR selectivity.

Key Points: 
  • Sunvozertinib, which was granted Breakthrough Therapy Designation by US FDA and China NMPA, is a rationally designed, oral, potent EGFR Exon20ins inhibitor, with wild-type EGFR selectivity.
  • Updated findings from the studies were presented at 2022 WCLC.
  • As of April 30, 2022, in platinum-pretreated patients (n=119), the best ORR (at the RP2D of 300mg QD) assessment according to RECIST guidelines (version 1.1) was 52.4%.
  • In patients with baseline brain metastasis, the best ORR at 300 mg QD reached 44%.

Genentech’s Subcutaneous Formulation of Tecentriq Demonstrates Positive Phase III Results

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Tuesday, August 2, 2022
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq (atezolizumab) met its co-primary endpoints.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMscin001 study evaluating a subcutaneous formulation of Tecentriq (atezolizumab) met its co-primary endpoints.
  • The safety profile of the subcutaneous formulation was consistent with that of IV Tecentriq.
  • IMscin001 is a Phase Ib/III, global, multicenter, randomized study evaluating the pharmacokinetics, safety and efficacy of the subcutaneous formulation of Tecentriq, compared with IV Tecentriq, in patients with previously treated locally advanced or metastatic NSCLC for whom prior platinum therapy has failed.
  • The investigational subcutaneous formulation combines Tecentriq with Halozyme Therapeutics Enhanze drug delivery technology.

ImmunityBio Announces FDA Acceptance of Biologics License Application for N-803 in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer Carcinoma In Situ

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Thursday, July 28, 2022
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This combination of N-803 with BCG is ImmunityBios first BLA to reach this stage of FDA acceptance for review.

Key Points: 
  • This combination of N-803 with BCG is ImmunityBios first BLA to reach this stage of FDA acceptance for review.
  • It represents an essential step in the clinical demonstration of the Nant Cancer Vaccine hypothesis proposed by ImmunityBios founder, Patrick Soon-Shiong, M.D.
  • It is currently being studied in trials for non-muscle-invasive bladder cancer, pancreatic cancer, non-small-cell lung cancer, non-Hodgkins lymphoma, and HIV.
  • ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof.

Calithera Biosciences Shares Progress in Sapanisertib and Mivavotinib Clinical Programs at Upcoming Lung Cancer and Lymphoma Conferences

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Wednesday, July 13, 2022
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SOUTH SAN FRANCISCO, Calif., July 13, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, announced that updates related to the ongoing clinical programs for sapanisertib (CB-228) and mivavotinib (CB-659) will be presented at the upcoming International Association for Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) and the 2022 Pan Pacific Lymphoma Conference, respectively.

Key Points: 
  • The phase 2 trial ( NCT05319028 ), which enrolled its first patient in June, is an open-label study of mivavotinib monotherapy in patients with relapsed/refractory non-GCB (ABC) diffuse large B-cell lymphoma (DLBCL).
  • Data from this trial could position Calithera to initiate a study with registrational intent in biomarker-specific DLBCL populations.
  • Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations.
  • The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all.

Novocure Enrolls First Patient in KEYNOTE-B36, a Pilot Study of Tumor Treating Fields Together with KEYTRUDA® for Patients with First-Line Stage III Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, June 21, 2022
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KEYNOTE-B36 represents one of Novocures five ongoing clinical trials exploring the potential of Tumor Treating Fields to complement immunotherapy agents.

Key Points: 
  • KEYNOTE-B36 represents one of Novocures five ongoing clinical trials exploring the potential of Tumor Treating Fields to complement immunotherapy agents.
  • We look forward to continuing our studies in partnership with Merck in hopes of treating many more patients in need.
  • KEYNOTE-B36 is a single arm, open-label phase 2 pilot study expected to enroll 66 patients.
  • Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Qualigen Therapeutics to Present at BIO International Convention

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Tuesday, June 14, 2022
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CARLSBAD, Calif., June 14, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces that Qualigen Therapeutics will present a corporate overview at the BIO International Convention to be held on June 13 16, 2022 at the San Diego Convention Center.

Key Points: 
  • CARLSBAD, Calif., June 14, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces that Qualigen Therapeutics will present a corporate overview at the BIO International Convention to be held on June 13 16, 2022 at the San Diego Convention Center.
  • Presenter Tariq Arshad MD, MBA, Chief Medical Officer, Qualigen Therapeutics
    Michael Poirier, Qualigen's Chairman and Chief Executive Officer, commented, BIOs International Convention is one of the industrys premier partnering conferences.
  • We see this presentation as an important opportunity to continue to establish our presence in the therapeutics arena, in particular, and are honored by the opportunity to present our story in this forum.
  • For more information about Qualigen Therapeutics, Inc., please visit www.qualigeninc.com .

Qualigen Therapeutics Announces IND-Enabling Studies to Advance Lead Program QN-302 Toward Clinical Trials

Retrieved on: 
Tuesday, June 7, 2022
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CARLSBAD, Calif., June 07, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces it has initiated Investigational New Drug, or IND-enabling, studies for its lead therapeutic program, QN-302. These initial safety and pharmacology studies represent an important milestone for QN-302, which is being developed to treat pancreatic cancer, and potentially prostate cancer and other solid tumors.

Key Points: 
  • The Company also announces that it has established an in vivo maximum tolerated dose of QN-302, which corroborates a therapeutic window for target indications as demonstrated in earlier efficacy studies.
  • Tariq Arshad, M.D., Qualigen's Chief Medical Officer, commented, To date, we are on target to hit our key milestones regarding the pre-clinical development of our exciting lead program QN-302.
  • We are encouraged by the progress we have made through these initial IND-enabling studies, and we are confident that we will continue to advance this program towards clinical trials within budget and on schedule.
  • QN-302 is Qualigens G-quadruplex (G4)-selective transcription inhibitor platform being developed as a potential treatment for PDAC, in addition to other tumors of high unmet clinical need.

Data Presented at ASCO Demonstrate Trilaciclib Helps Protect Against Severe Neutropenia, Severe Anemia, and Severe Thrombocytopenia When Given to Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Patients Prior to Chemotherapy

Retrieved on: 
Thursday, June 2, 2022
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RESEARCH TRIANGLE PARK, N.C., June 02, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced results of a post-hoc study analysis showing that ES-SCLC patients who received trilaciclib prior to chemotherapy had a lower incidence of single- and multilineage myelosuppressive events—fewer cases of severe neutropenia, severe anemia, and severe thrombocytopenia—compared to patients receiving placebo. Moreover, the proportion of patients who experienced at least one multilineage myelosuppressive event was lower in the trilaciclib arm compared to the placebo arm. The data, derived from a post-hoc analysis of Phase 2 trials, were presented in a poster at the 2022 American Society of Clinical Oncology (ASCO) annual meeting.

Key Points: 
  • Moreover, the proportion of patients who experienced at least one multilineage myelosuppressive event was lower in the trilaciclib arm compared to the placebo arm.
  • Only severe grade events (grade 3 per the National Cancer Institute) were included in the analysis, and 75 percent of patients were in the first-line setting.
  • In the United States, approximately 30,000 small cell lung cancer patients are treated annually.
  • SCLC, one of the two main types of lung cancer, accounts for about 10% to 15% of all lung cancers.

Lung Cancer Mutation Consortium Sites Initiate LEADER Trial

Retrieved on: 
Thursday, June 2, 2022
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NEW YORK, June 2, 2022 /PRNewswire/ -- The Lung Cancer Mutation Consortium (LCMC), facilitated by the Lung Cancer Research Foundation (LCRF), announces the initiation of trial sites at USC Norris Cancer Center, University of California-Davis, University of Michigan, and University of Washington for its fourth study, LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer (LEADER), examining targeted drugs given as single agents and combinations as neoadjuvant therapies matched to specific genetic mutations.

Key Points: 
  • NEW YORK, June 2, 2022 /PRNewswire/ -- The Lung Cancer Mutation Consortium (LCMC), facilitated by the Lung Cancer Research Foundation (LCRF), announces the initiation of trial sites at USC Norris Cancer Center, University of California-Davis, University of Michigan, and University of Washington for its fourth study, LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer (LEADER), examining targeted drugs given as single agents and combinations as neoadjuvant therapies matched to specific genetic mutations.
  • The trial is now open for enrollment and is expected to include more than twenty trial sites, with investigators from across the country.
  • LCRF's mission is to improve lung cancer outcomes by funding research for the prevention, diagnosis, treatment, and cure of lung cancer.
  • Focused on deepening our understanding of the genetic changes that underlie lung cancers and on improving outcomes in patients whose tumors harbor these oncogenic drivers, the Lung Cancer Mutation Consortium (LCMC) is an association of more than twenty U.S. cancer centers.