Endometrial cancer

Zymeworks Presents New Data from Multiple Preclinical Development Programs at 2024 American Association for Cancer Research Annual Meeting

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Monday, April 8, 2024
Well, Small-cell carcinoma, Therapeutic index, Glomus tumor, Endometrial cancer, Survival, Environment, Service provider, Trichloroethylene, Patient, Primate, Triple-negative breast cancer, Lead, Zymeworks, 3D, Standard of care, Cancer, TAA, Spacecraft, Lung cancer, IND, CD3, DLL3, AACR, Workflow, Antibody, TCE, CD28, Therapy, Stomach, ADC, Vaccine

The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.

Key Points: 
  • The compelling preclinical activity profile supports ZW191 development across multiple tumor types, including FRα-high/mid/low ovarian cancers and other FRα-expressing indications, including non-small cell lung cancer, endometrial cancer, and triple-negative breast cancer.
  • An investigational new drug (IND) submission or foreign equivalent is planned for 2024.
  • Small cell lung cancer (SCLC) is an aggressive neuroendocrine cancer with a poor prognosis and high unmet medical need2.
  • Displays no cross-linking of T cells and exhibits obligate cis T cell binding of CD28, requiring co-engagement of CD3.

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

Retrieved on: 
Tuesday, April 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.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

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Friday, March 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.

Sutro Biopharma Reports Full Year 2023 Financial Results, Business Highlights and Select Anticipated Milestones

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Monday, March 25, 2024
CBFA2T3, Endometrial cancer, NSCLC, ASH, AML, International, Part, Patient, SAN, STRO, Acute myeloid leukemia, Cancer, Spacecraft, Lung cancer, RAM, PROC, Investment, Phenotype, Society, ADC, Hematology, Nursing

SOUTH SAN FRANCISCO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today reported its financial results for the full year 2023, its recent business highlights, and a preview of select anticipated milestones.

Key Points: 
  • “The year 2023 was pivotal for Sutro, with the initiation of REFRαME-O1, our registration-directed study of luvelta for platinum-resistant ovarian cancer (PROC) patients, further validating our next-generation ADC capabilities.
  • The registration-directed trial, REFRαME-O1, for treatment of PROC is enrolling, with an anticipated ~140 sites in ~20 countries to be opened by the end of 2024.
  • Upon exercising the option, Vaxcyte paid Sutro $50 million and is obligated to pay Sutro an additional $25 million within six months.
  • Upon the occurrence of certain regulatory milestones, Vaxcyte would be obligated to pay Sutro up to an additional $60 million.

Positive RUBY phase III data show potential for Jemperli (dostarlimab-gxly) combinations in more patients with primary advanced or recurrent endometrial cancer

Retrieved on: 
Saturday, March 16, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, OS, Food and Drug Administration, Endometrial cancer, Progression-free survival, Risk, GSK, Patient, Aes, Death, MD, Nature, Clinical trial, Copenhagen University Hospital, Gynecologic Oncology (journal), Division, PFS, Food, Pharmaceutical industry

2 Exploratory analyses of OS in dMMR/MSI-H and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing.

Key Points: 
  • 2 Exploratory analyses of OS in dMMR/MSI-H and OS in MMRp/MSS populations were pre-specified with no planned hypothesis testing.
  • RUBY Part 2: addition of niraparib to dostarlimab-gxly in maintenance setting significantly improved PFS in first-line primary advanced or recurrent endometrial cancer compared to chemotherapy alone, meeting the primary endpoint of the trial.
  • Discontinuation of dostarlimab-gxly or placebo due to a TEAE occurred in 24.1% of patients in the treatment arm and 5.2% of patients in the control arm.
  • Discontinuation of niraparib or placebo due to a treatment-emergent AE occurred in 15.7% of patients in the treatment arm and 4.2% of patients in the control arm.

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

Retrieved on: 
Tuesday, April 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, Neoplasm, NDA, Cancer, Breakthrough therapy, Senior, HCM, HKEX, Dor, IRC, Prognosis, PFS, Ophthalmology, Pharmaceutical industry

The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase 2 study investigating sintilimab in combination with fruquintinib in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity  with treatment on platinum-based doublet chemotherapy.
  • We are excited about the NDA acceptance and priority review designation, which increases our potential to bring a new treatment option to endometrial cancer patients, and concurrently strengthens the leadership position of TYVYT® in China."
  • We look forward to bringing this much-awaited treatment advancement to endometrial cancer patients to improve their treatment outcome."
  • The NMPA granted Breakthrough Therapy designation to the combination of sintilimab and fruquintinib for this potential indication in July 2023.

Aadi Bioscience Presents New Subgroup Analysis of Patients with Advanced Malignant PEComa of Gynecologic Origin Treated with nab-Sirolimus at Society of Gynecologic Oncology (SGO)

Retrieved on: 
Sunday, March 17, 2024
TSC1, Ovarian cancer, AADI, Endometrial cancer, Perivascular epithelioid cell tumour, EEC, Cervical cancer, Patient, Neoplasm, Cancer, Trial of the century, University, SGO, MD, Malignancy, Society, Safety, Gynecologic Oncology (journal), TSC2, FDA, Glomus tumor, Aadi, Pharmaceutical industry

LOS ANGELES, March 17, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced patients in the AMPECT trial whose malignant perivascular epithelioid cell tumor (PEComa) had gynecologic origins experienced efficacy and safety consistent with the overall study population. The AMPECT trial formed the basis for the FDA approval of the company's nab-sirolimus, FYARRO®, for advanced malignant PEComa regardless of mutational status. This new subgroup analysis will be presented during an oral plenary at the Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, CA on March 17, 2024.

Key Points: 
  • The AMPECT trial formed the basis for the FDA approval of the company's nab-sirolimus, FYARRO®, for advanced malignant PEComa regardless of mutational status.
  • This new subgroup analysis will be presented during an oral plenary at the Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, CA on March 17, 2024.
  • "Overactivation of the mTOR pathway has been implicated in gynecological cancers," said Loretta Itri, MD, Chief Medical Officer at Aadi.
  • "nab-Sirolimus is a nanoparticle albumin-bound (nab) mTOR inhibitor under investigation in TSC1- and TSC2-mutated tumors as well as other mTOR-driven tumors.

Caris Life Sciences to Showcase Research at 2024 SGO Annual Meeting on Women's Cancer

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Wednesday, March 13, 2024
Diagnosis, PR, UCS, NCI, Ovarian cancer, Promise, OSCC, Survival, EEC, Exome sequencing, Glomus tumor, TMB, Patient, Neoplasm, NGS, Biomarker, Research, DNA, RNA, Cancer, AI, SGO, Carcinosarcoma, MD, Endometrial cancer, Medicine, Abstract, POA, Prognosis, Poster, ETS, Medical imaging

IRVING, Texas, March 13, 2024 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, announced today that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present three studies across multiple gynecological tumor types at the 2024 SGO Annual Meeting on Women's Cancer, March 16-18, 2024, in San Diego. The findings demonstrate the power of Caris' comprehensive multi-modal database, generated by examining every gene, to enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment.

Key Points: 
  • The findings demonstrate the power of Caris' comprehensive multi-modal database, generated by examining every gene
    "We are proud to return and present an array of precision oncology research at this year's SGO Annual Meeting.
  • The Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE) criteria classify four molecular subtypes of endometrial tumors (ET).
  • Poster and abstract summaries highlighting the Caris research presented at SGO 2024 will be available onsite at Caris' booth (#601).
  • The POA includes 91 cancer centers, academic institutions, research consortia and healthcare systems, including 43 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research.

IDEAYA Announces Clinical Collaboration to Evaluate IDE161 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Endometrial Cancer

Retrieved on: 
Tuesday, March 12, 2024
MSD, PARG, Apoptosis, Prostate cancer, Endometrial cancer, Colorectal cancer, RECIST, Patient, MSI, Merck & Co., Pembrolizumab, Medicine, MSS, Breast cancer, HRD, Therapy, ADP, PD-1, Pharmaceutical industry

"We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.

Key Points: 
  • "We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences.
  • "We are very pleased to collaborate with Merck on this trial evaluating IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer.
  • Under the clinical trial collaboration and supply agreement, Merck will provide KEYTRUDA to IDEAYA, which will be the sponsor of the Phase 1 clinical combination trial.
  • The mechanistic rationale and preclinical data to support the IDE161 and PD-1 clinical combination will be provided as part of a future R&D update.

Iovance Biotherapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates 

Retrieved on: 
Wednesday, February 28, 2024
IOV, NSCLC, Acquisition, Cohort, Units of paper quantity, Research, MAA, TIL, Information, FDA, Melanoma, Food, Cancer, Growth, U.S. FDA, PD-1, European, Interim, Safety, NDS, Endometrial cancer, Food and Drug Administration, Second generation, Patent, Patient, MMR, Clinical trial, Investment, Intellectual property, Travel, Pharmaceutical industry

SAN CARLOS, Calif., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported fourth quarter and full year 2023 financial results and corporate updates.

Key Points: 
  • The Iovance Cell Therapy Center ( iCTC ) began commercial manufacturing for Amtagvi patients within a week of approval.
  • More than 700 patients have been treated with Iovance TIL therapy manufactured using proprietary Iovance processes as of December 31, 2023.
  • Revenue for the fourth quarter and year ended December 31, 2023, was $0.5 million and $1.2 million, respectively, and comprised of product sales following the Proleukin® acquisition in May 2023.
  • Research and development expenses were $87.5 million for the fourth quarter ended December 31, 2023, an increase of $6.9 million compared to $80.6 million for the same period ended December 31, 2022.