PFS

BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR

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화요일, 4월 9, 2024
HER2, ILD, CPI, Survival, Progression-free survival, Central nervous system, Patient, CNS, History, Death, Eribulin, Spacecraft, MD, CBR, TPC, EMBRACE, Life, BCT, AACR, TSX, Therapy, Breast cancer, Safety, Poster, CMO, PFS, ADC, PD-1, Pharmaceutical industry

“ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.

Key Points: 
  • “ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.
  • To our knowledge, there are no effective treatment options in this patient population for whom the progression-free survival prognosis is only a few weeks.
  • BriaCell will be monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer.
  • Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study.

Junshi Biosciences Announces Approval of the sNDA for Toripalimab for the 1st-Line Treatment of Renal Cancer

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일요일, 4월 7, 2024
Diagnosis, OS, Nephrectomy, Immunotherapy, DCR, Oncology, Risk, Patient, Shanda, Malignancy, Death, IMDC, Carcinoma, Renal cell carcinoma, Trial of the century, RCC, National Medical Products Administration, ESMO, HKEX, IRC, PFS, Annals of Oncology, Axitinib, Independent Review Committee, Pharmaceutical industry

Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.

Key Points: 
  • Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma.
  • There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022.
  • Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy.
  • “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China.

eFFECTOR Therapeutics Announces Topline Results of Phase 2 KICKSTART Trial of Tomivosertib Combined with Pembrolizumab in Non-Small Cell Lung Cancer

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목요일, 4월 4, 2024
Fulvestrant, KICKSTART, Survival, NSCLC, AML, Patient, Acute myeloid leukemia, Cancer, Hope, Pembrolizumab, Lung cancer, Therapy, Breast cancer, Safety, Cox, PFS, Interval (mathematics), Effector, Pharmaceutical industry

The two-sided p value for PFS, based on a stratified log rank test, was 0.21, which did not meet the pre-specified threshold of p≤0.2.

Key Points: 
  • The two-sided p value for PFS, based on a stratified log rank test, was 0.21, which did not meet the pre-specified threshold of p≤0.2.
  • The median PFS was 13.0 weeks in the tomivosertib plus pembrolizumab arm and 11.7 weeks in the placebo plus pembrolizumab arm, respectively.
  • There were 67% Grade 3 or higher treatment emergent adverse events in the tomivosertib plus pembrolizumab arm versus 37% in the placebo plus pembrolizumab arm.
  • “We sincerely appreciate the contributions of all the patients, their families, and trial site professionals who contributed to the execution of the trial.

Over 52 Million Myeloma Warriors Reached, Creating Ripples Across the Globe for #MyelomaACTIONMonth

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목요일, 4월 4, 2024
Well, Organization, Bone marrow, Development, Learning, NLB, Walking, MAM, Disease, Empathy, Caregiver, Education, Patient, Social media, Research, Running, Hope, Wall, IMF, Quality of life, Marketing, International Myeloma Foundation, Huge, PFS, Human

“From South Korea to Portugal, India to Poland, all myeloma communities spoke as one voice once more for Myeloma Action Month!

Key Points: 
  • “From South Korea to Portugal, India to Poland, all myeloma communities spoke as one voice once more for Myeloma Action Month!
  • Beyond the numbers, this year’s #MyelomaACTIONMonth global campaign created ripples through the power of each myeloma story shared.
  • These ripples converged to create a mighty wave of awareness for multiple myeloma across the globe.
  • Sessions included Myeloma 101 & Understanding Your Labs, Financial Considerations in Myeloma, and Symptom Management and Living Well with Myeloma and much more.

MacroGenics Provides Phase 2 TAMARACK Study Early Interim Safety Data and Plans for Future Disclosures

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수요일, 4월 3, 2024
Docetaxel, Prostate cancer, ECOG, B7-H3, Patient, Cancer, Autumn, Society, Safety, ASCO, Therapy, PFS, ADC, Annual general meeting, Pharmaceutical industry

As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31.

Key Points: 
  • As previously disclosed, safety data from the Company’s ongoing TAMARACK Phase 2 study was submitted in early February to the American Society of Clinical Oncology (ASCO) for presentation at the upcoming Annual Meeting that begins May 31.
  • The abstract containing this early interim data, based on a January 4, 2024 data cut-off, was not accepted.
  • TAMARACK is an ongoing randomized, open-label, Phase 2 dose selection study assessing the efficacy, safety, and tolerability of two dose levels of vobra duo (2.0 mg/kg and 2.7 mg/kg IV Q4W).
  • At data cutoff (Jan 4, 2024), 182 pts with mCRPC enrolled on TAMARACK, of which 177 received vobra duo.

Porsche Financial Services strengthens leadership team

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화요일, 4월 2, 2024
Bugatti, Moses Austin, CRM, SVKM's NMIMS, University of Illinois Urbana-Champaign, Strategic management, Management information system, University, Business administration, Kellogg School, Temple University, Marketing communications, IPO, MBA, Northwestern University, Digital transformation, Northern Illinois University, Capital market, Term, Florida State University, BBA, PFS, Treasury, Customer service, Management

Atlanta, April 02, 2024 (GLOBE NEWSWIRE) -- Porsche Financial Services, Inc. (PFS) announced today the appointment of four new vice presidents to key leadership positions.

Key Points: 
  • Atlanta, April 02, 2024 (GLOBE NEWSWIRE) -- Porsche Financial Services, Inc. (PFS) announced today the appointment of four new vice presidents to key leadership positions.
  • "Following the Porsche IPO in September 2022, Porsche Financial Services has continued to evaluate how the organization can most effectively support its continued growth plan,” said Ross Dupper, President and CEO of Porsche Financial Services.
  • John Claiborne, VP Digital Transformation and Data Intelligence: John began his career with Porsche in 2001 as an IT contractor and has since held positions with increasing technical and management responsibility with Porsche Business Services, Porsche Cars North America, and Porsche Financial Services, where he managed the US launch of exclusive brand financial services for Bentley, Lamborghini, and Bugatti in 2012.
  • As the dedicated financial services company for Porsche Cars North America, PFS provides custom financial solutions and products to Porsche customers and dealers in the United States and Canada.

Vaccinex Reports 2023 Financial Results and Provides Corporate Update

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화요일, 4월 2, 2024
8-K, Research, Cash, Prevalence, HNSCC, Patient, Biomarker, Microglia, Sale, Nature, Form 10-K, Cancer, Neuroinflammation, Neuron, Neoplasm, Cognition, Drug development, Head and neck cancer, Astrocyte, PFS, Security, Neurodegenerative disease, Pharmaceutical industry

ROCHESTER, N.Y., April 02, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the fourth quarter ended December 31, 2023 and provided a corporate update on key programs.

Key Points: 
  • ROCHESTER, N.Y., April 02, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced financial results for the fourth quarter ended December 31, 2023 and provided a corporate update on key programs.
  • Vaccinex achieved several important clinical milestones for pepinemab in both Alzheimer’s disease and Head and Neck Cancer.
  • Financial Results for the Year Ended December 31, 2023:
    Cash and Cash Equivalents and Marketable Securities.
  • The Company effected a 1-for-15 reverse stock split in Q3 2023 and 1-for-14 reverse stock split in Q1 2024.

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

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화요일, 4월 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Gritstone bio Announces Positive Preliminary Progression-free Survival and Long-term Circulating Tumor DNA (ctDNA) Data from Phase 2 Portion of Ongoing Phase 2/3 Study of its Personalized Cancer Vaccine, GRANITE, in Front-line Metastatic Microsatellite St

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월요일, 4월 1, 2024
Lung cancer, Survival, Immunotherapy, Disease, Colorectal cancer, Progression-free survival, Medicine, Patient, Common, DNA, Aes, Cancer, Death, Doctor of Philosophy, Gritstone bio, MD, Kinetics, Induction chemotherapy, MSS, Circulating tumor DNA, VAF, Melanoma, PFS, Vaccine, Data, UCLA, Liver disease, Neoplasm, Pharmaceutical industry

EMERYVILLE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced positive preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC). The randomized, controlled, open-label study is designed to quantify the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint blockade in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression free survival (PFS) data show an early trend in benefit for GRANITE patients (HR=0.82, [95% CI, 0.34-1.67]; 62% censored) and extended PFS benefit in high-risk patients (HR=0.52 [95% CI, 0.15-1.38]; 44% censored), in whom progression occurs faster. Circulating tumor DNA (ctDNA) analysis over several months of treatment shows the expected relationship with disease progression and favors GRANITE, while short-term ctDNA response analysis (molecular response as defined per protocol) did not demonstrate a difference between study arms. Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).

Key Points: 
  • Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).
  • “Today's preliminary Phase 2 results are highly encouraging and represent the first randomized trial evidence, albeit early, that a personalized neoantigen-directed vaccine can potentially drive efficacy in a metastatic ‘cold’ tumor.
  • Fortunately, long-term analysis demonstrates the expected correlation of ctDNA with clinical benefit and favors GRANITE patients.
  • This analysis was performed on 44 patients who received study treatment (control and GRANITE arms) and have available baseline ctDNA data.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

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금요일, 3월 29, 2024
Head, Immunotherapy, HNSCC, Patient, Roche, Lead, Immunoglobulin G, Neoplasm, CRC, Audit committee, PD-1, Observation, Bioinformatics, Colorectal cancer, SAN, Information technology, Pembrolizumab, PRS, Safety, PD-L1, Compensated emancipation, Annual report, Apoptosis, Cervical cancer, Part, Merck, Senior, Bevacizumab, MSS, GAAP, ASCO, PFS, MTD, Liver disease, HCC, Therapeutic index, Endometrial cancer, Progression-free survival, ADS, Net, Regulatory T cell, Research and development, Liver, Pharmaceutical industry

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.