CR

Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

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Mercoledì, Maggio 29, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Bristol Myers Squibb, Patient, Progression-free survival, Mesothelioma, Renal cell carcinoma, Neck, ESCC, Risk, Colorectal cancer, Recurrence, Lung cancer, BMY, PFS, Netherlands Cancer Institute, Head, Cisplatin, NSCLC, Cancer, EAC, Congress, GEJ, Civil service commission, European Commission, HR, Death, Melanoma, PR, ESMO, Jan-Arie van der Heijden, European, Checkmate, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC).
  • With this approval, Opdivo in combination with cisplatin and gemcitabine becomes the first concurrent immunotherapy-chemotherapy approved for the treatment of adult patients with unresectable or metastatic UC in the first-line setting in the European Union.
  • “With today’s approval by the EC, we’re pleased to be able to offer Opdivo concurrently with chemotherapy to eligible patients with unresectable or metastatic UC,” said Dana Walker, M.D., M.S.C.E., vice president and global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb.
  • “This is a major step forward for this patient population and reinforces our goal of advancing and delivering new options to patients with difficult-to-treat cancers.

CG Oncology to Present Positive Final Results from Phase 2 CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in BCG-Unresponsive High-Risk NMIBC at ASCO 2024 Annual Meeting

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Venerdì, Maggio 24, 2024
Merck & Co., Progression-free survival, Pembrolizumab, Kaplan–Meier estimator, CFS, Toxicity, Metastasis, Bladder cancer, Carcinoma, FDA, PFS, Safety, Fast track (FDA), MD, ITT, ASCO, Merck, CIS, NMIBC, Society, Carcinoma in situ, Dor, Annual general meeting, Pharmaceutical industry

The data will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting from May 31-June 4, in Chicago, IL.

Key Points: 
  • The data will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting from May 31-June 4, in Chicago, IL.
  • “There is a significant unmet need for new and innovative treatments for patients suffering with bladder cancer.
  • As of May 17, 2024, the CR rate in the ITT population at 24 months was 54% (19/35) (95% CI, 37-71%).
  • To learn more about the results from BOND-003 you may read the Company’s press release issued on May 3, 2024.

Compass Therapeutics to Present Phase 1 Data for CTX-471, A Novel CD137 Agonist Antibody, Demonstrating Anti-Tumor Activity in Patients Who Have Progressed on Approved PD-1 or PD-L1 Inhibitors at the American Society of Clinical Oncology (ASCO) Annual Mee

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Giovedì, Maggio 23, 2024
SCLC, R&D, PET, Patient, Mesothelioma, Pharmacokinetics, Thrombocytopenia, Liver, News, Male, Therapy, Malignancy, Safety, Carcinoma, PD-1, Melanoma, Incidence, PR, Aes, PD-L1, Combination therapy, Pharmaceutical industry

Five clinical responses were observed, all in patients who previously received checkpoint inhibitors.

Key Points: 
  • Five clinical responses were observed, all in patients who previously received checkpoint inhibitors.
  • A durable partial response (PR) in a patient with small-cell lung cancer (SCLC) converted to a complete response, as confirmed by PET scan.
  • Four additional PRs were also observed, 3 of 11 (27.3%) patients with melanoma (2 confirmed, one unconfirmed) and one of four (25%) patients with mesothelioma (PR confirmed).
  • CTX-471 monotherapy was observed to be generally well-tolerated, with the majority of adverse events (AEs) being Grade 1-2.

HOOKIPA Pharma Announces Positive Clinical Data to be Presented at the American Society for Clinical Oncology 2024 Annual Meeting

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Giovedì, Maggio 23, 2024
HLA, Patient, Progression-free survival, Abstract (summary), Survival, Arenavirus, Pembrolizumab, IIT, Neck, OPC, University, CDT, Overalls, Neoplasm, Head, Safety, Disease, CPS, Cancer, ASCO, Mutation, Chemoradiotherapy, Peptide, CD8, PD-L1, DCR, Annual general meeting, Oropharyngeal cancer, Pharmaceutical industry

The abstract reported data as of January 12, 2024, and included 42 patients treated with HB-200 plus pembrolizumab.

Key Points: 
  • The abstract reported data as of January 12, 2024, and included 42 patients treated with HB-200 plus pembrolizumab.
  • This subpopulation is representative of patients eligible for the Company’s pivotal Phase 2/3 trial, which will begin enrolling patients in the fourth quarter of 2024.
  • Additional data will be presented in the Head and Neck Oral Abstract Session at the ASCO 2024 Annual Meeting on June 4, at 11:09 a.m. CDT.
  • During the presentation, preliminary progression-free survival and overall survival data will be shared for the first time.

IIHS, Consumer Reports name safe, affordable vehicles for teens

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Mercoledì, Maggio 22, 2024
Insurance, Pedestrian, SAFETY, Parent, Hyundai Ioniq 6, Risk, AEB, Hyundai, Safety, NHTSA, ESC, EVS, Certification, Crash, Research, IIHS, Kelley Blue Book, Acceleration, Road

These vehicles are also great choices for those with younger children who might be taking the wheel of the family vehicle in several years.

Key Points: 
  • These vehicles are also great choices for those with younger children who might be taking the wheel of the family vehicle in several years.
  • The list also has no minicars or vehicles under 2,750 pounds because small, light vehicles may not provide enough protection in crashes with other vehicles.
  • The new vehicles have average or better predicted reliability from CR and meet the same standard for emergency handling as the used vehicles.
  • Unlike gas engines, electric motors give drivers immediate access to all of the vehicle’s power, so parents should take extra caution when giving these vehicles to teens.

Immutep Presents Data from Safety Lead-in Phase of AIPAC-003 at ESMO Breast 2024

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Mercoledì, Maggio 15, 2024
ASX, Patient, CD4, Plasma, MBC, Pharmacodynamics, Safety, Autoimmune disease, RECIST, IMM, Poster, Congress, Blood, CDK, Cancer, Eftilagimod alpha, MHC, Paclitaxel, ESMO, Oncology, CD8, TNBC, Gamma ray, MHC class II, Pharmaceutical industry

SYDNEY, AUSTRALIA, May 15, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces encouraging efficacy, safety, and pharmacodynamic data from the safety lead-in of the AIPAC-003 Phase II/III trial presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2024 Congress. This lead-in represents the first ever 90mg dosing of eftilagimod alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist, given in combination with weekly paclitaxel.

Key Points: 
  • During the immuno-oncology (IO)-chemotherapy treatment of efti and paclitaxel, this patient achieved a partial response (PR) that subsequently turned into a CR.
  • As of the data cut-off (April 3), no dose-limiting toxicities and no treatment-emergent adverse events of grade 3 or higher severity were recorded.
  • Further data updates in terms of safety and efficacy from AIPAC-003 are expected in CY2024.
  • The ESMO Breast 2024 poster will be available on the Posters & Publications section of Immutep’s website.

Shattuck Labs to Present Additional Data from the Phase 1B Dose Expansion Clinical Trial of SL-172154 with Azacitidine (AZA) in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) Patients at the E

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Martedì, Maggio 14, 2024
Patient, MDS, Cardiovascular disease, Hypokalemia, CRi, Cardiac arrest, AZA, Febrile neutropenia, Karyotype, Autoimmune disease, IRR, Congress, AML, EHA, Cancer, CD40, Fatigue, Myocardial infarction, Cytokine release syndrome, History, Pharmaceutical industry

AUSTIN, TX and DURHAM, NC, May 14, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced the presentation of additional data from the Phase 1B dose expansion clinical trial of SL-172154 with AZA in frontline HR-MDS and TP53m AML patients. These data will be featured in a poster presentation at the EHA 2024 Congress, being held June 13-16, 2024, both virtually and in Madrid, Spain.

Key Points: 
  • These data will be featured in a poster presentation at the EHA 2024 Congress, being held June 13-16, 2024, both virtually and in Madrid, Spain.
  • “The complete response rate in HR-MDS increased by the February 1st data cutoff, and the ORR increased in the TP53m AML cohort.
  • This is encouraging because many patients were still early in their course of treatment.
  • EHA poster presentation to include additional data from the next planned cutoff in the second quarter of 2024.

CARGO Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update

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Martedì, Maggio 14, 2024
Patient, Progression-free survival, Survival, CD2, Health, Stanford University, CD19, Therapy, IND, PFS, Trial of the century, Disease, Drug development, Safety, SAN, Cytokine release syndrome, IDMC, Congress, EHA, Cancer, IPO, OS, Research, Research and development, Administration, CRS, Pharmaceutical industry

SAN CARLOS, Calif., May 14, 2024 (GLOBE NEWSWIRE) --  CARGO Therapeutics, Inc. (NASDAQ: CRGX), a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.

Key Points: 
  • Cash Position: As of March 31, 2024, CARGO had cash, cash equivalents and marketable securities of $375.9 million, providing expected cash runway into 2026.
  • Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2024 were $30.5 million, which included $1.7 million of non-cash stock-based compensation expense.
  • General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2024 were $10.3 million, which included $2.2 million of non-cash stock-based compensation expense.
  • Net Loss: Net loss for the first quarter of 2024 was $35.8 million, or $0.87 per share, including non-cash stock-based compensation and depreciation expenses of $3.9 million and $0.6 million, respectively.

BRUKINSA® Data at ASCO Underscore Differentiated Clinical Profile for Treatment of CLL and SLL

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Venerdì, Maggio 24, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Patient, ASCEND, Chronic lymphocytic leukemia, Risk, Network, Clinical trial, University, Rituximab, PFS, Meta-analysis, Safety, Acalabrutinib, University of Washington, CLL, Blood, Abstract, Newsroom, ASCO, SLL, Associate, Lymphocytosis, BTK, Society, Hematology, BGNE, Survival, Annual general meeting, Pharmaceutical industry

“At this year’s ASCO, multiple presentations continue to add to our extensive body of evidence demonstrating BRUKINSA’s uniquely differentiated clinical profile,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.

Key Points: 
  • “At this year’s ASCO, multiple presentations continue to add to our extensive body of evidence demonstrating BRUKINSA’s uniquely differentiated clinical profile,” Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
  • Results should be viewed in the context of analysis limitations and available randomized clinical trial data.
  • Data from this analysis provide important insights when evaluating the overall safety profile of individual BTKi treatments.
  • For additional information about BeiGene’s presence at the 2024 ASCO Annual Meeting, please visit our meeting hub in our newsroom .

Syros Reports First Quarter 2024 Financial Results and Provides a Corporate Update

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Martedì, Maggio 14, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Patient, MDS, Loan agreement, Pfizer, Venetoclax, RARA, Food, Clinical trial, Bone marrow, IDMC, AML, ID, Research, G&A, Azacitidine, Webcast, Pharmaceutical industry

Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today reported financial results for the quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today reported financial results for the quarter ended March 31, 2024 and provided a corporate update.
  • The Company did not recognize any revenue in the first quarter of 2024, as compared to $3.0 million for the first quarter of 2023.
  • Research and development (R&D) expenses were $24.7 million for the first quarter of 2024, as compared to $28.8 million for the first quarter of 2023.
  • ET to discuss the first quarter 2024 financial results and provide a corporate update.