Everolimus

Aadi Bioscience to Present New Non-clinical Data Highlighting Combinability of nab-Sirolimus at the American Association for Cancer Research (AACR) Annual Meeting

Retrieved on: 
Tuesday, April 9, 2024
PI3K, AADI, Fulvestrant, Patient, AACR, Cancer, Breast cancer, HR, LOS, Everolimus, Pharmaceutical industry

LOS ANGELES, April 9, 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 it will present new non-clinical data that highlight the combinability of nab-sirolimus and its potential for synergy to enhance anti-cancer effects and overcome resistance. These data will be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, taking place April 5-10, 2024.

Key Points: 
  • Data further support clinical exploration of nab-sirolimus in combination with endocrine therapy for hormone-driven cancers, as is currently being investigated for patients with endometrioid-type endometrial cancer in a Phase 2 trial
    LOS ANGELES, April 9, 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 it will present new non-clinical data that highlight the combinability of nab-sirolimus and its potential for synergy to enhance anti-cancer effects and overcome resistance.
  • These data will be presented during poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA, taking place April 5-10, 2024.
  • Poster presentation details and abstract highlights include:
    Fulvestrant, the selective estrogen receptor degrader and PI3K inhibitors, such as alpelisib, have demonstrated efficacy in patients with HR+ PI3K-mutated breast cancer; however, resistance still occurs
    These data further support the combination of nab-sirolimus with endocrine therapy for hormone-driven cancers, as is currently being investigated in patients with advanced or recurrent endometrioid endometrial cancer in a Phase 2 study (NCT05997017)
    Corresponding with greater antitumor activity, nab-sirolimus was associated with higher intratumoral drug concentration and stronger mTOR target suppression than everolimus when the agents were combined with KRAS G12C inhibitors

Olema Oncology Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

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Monday, March 11, 2024
Breast cancer, SAN, Cancer, Investigational New Drug, Woman, ESMO, Biomedical Research, FDA, Everolimus, Corporation, Ribociclib, GAAP, SVB, Patient, Clinical trial, Novartis, Congress, Silicon Valley Bank, Oncology, Initiate, IND, Trial of the century, Research, Pharmaceutical industry

“In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.

Key Points: 
  • “In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer.
  • Presented palazestrant monotherapy Phase 2 clinical results at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, as an oral presentation demonstrating compelling activity in both wild-type and ESR1-mutant tumor types.
  • Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, respectively, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense respectively.
  • A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

Arvinas Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

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Tuesday, February 27, 2024
CDK4, ESPP, Research, BCL6, Sale, Exercise, LRRK2, ARVN, CDK7, ATM, HER2, Genentech, European Medicines Agency, Congress, Development, Breast cancer, Pfizer, CBR, ESMO, Everolimus, Greyhawk, ESR1, Oncology, Enrollment, Investment, Insurance, Prostate cancer, PFS, Food, Ribociclib, Bayer, Administration, Patient, Neutropenia, Pharmaceutical industry

NEW HAVEN, Conn., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • Median PFS of 11.1 and 11.0 months in patients with ESR1 wild-type and ESR1 mutant tumors, respectively.
  • Announced the appointment of Randy Teel, Ph.D., Arvinas’ current senior vice president of corporate and business development, to the role of interim chief financial officer and treasurer.
  • The Arvinas Board of Directors has launched a formal search process to identify Mr. Cassidy’s permanent replacement.
  • Revenues: Revenue was $78.5 million and $(43.1) million for the year and quarter ended December 31, 2023 as compared with $131.4 million and $38.0 million for the year and quarter ended December 31, 2022.

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 February 2024

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Saturday, February 10, 2024
Communication, Signal, PRAC, Civil service commission, COVID-19, Protein, European Commission, Everolimus, RMP, Vaccine, Health care, EMA, Risk, CHMP, Ritonavir, Immune system, Marketing, CYP3A, Data, Plasma protein binding, Tacrolimus, State, Medicine, Sirolimus, Disease

EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when…, Agenda Agenda of the PRAC meeting 5-8 February 2024DraftFirst published: 05/02/2024Last updated: 06/02/2024Reference Number: EMA/PRAC/11237/2024…, PRAC statistics: February 2024, PRAC statistics: February 2024First published: 09/02/2024 English (EN) (22.52 MB - PDF)View , Glossary:Safety signal assessments.

Key Points: 
  • EMA’s safety committee (PRAC) is reminding healthcare professionals of the risk of serious and potentially fatal adverse reactions with Paxlovid (nirmatrelvir, ritonavir) when…, Agenda Agenda of the PRAC meeting 5-8 February 2024DraftFirst published: 05/02/2024Last updated: 06/02/2024Reference Number: EMA/PRAC/11237/2024…, PRAC statistics: February 2024, PRAC statistics: February 2024First published: 09/02/2024 English (EN) (22.52 MB - PDF)View , Glossary:Safety signal assessments.
  • A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association between a medicine…, Ongoing referralsProcedureStatusUpdateHydroxyprogesterone-containing medicinal products – Article-31 referralUnder evaluationPRAC continued its assessment

Eisai Aims to Advance Genitourinary Cancer Treatment with New Research at ASCO GU 2024

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Thursday, January 18, 2024
Senior, Role, Renal cell carcinoma, Patient, Research, Meta-analysis, Rescue coordination centre, RCC, ASCO, Everolimus, Pivotal, Society, Apoptosis, Disease, Safety, Eisai, FDA, Abstract, Pharmaceutical industry

NUTLEY, N.J., Jan. 18, 2024 /PRNewswire/ --  Eisai announced today the presentation of research in renal cell carcinoma (RCC) during the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (#GU24) which is taking place in-person in San Francisco, California and online from January 25-27. Notable presentations include a rapid oral abstract session featuring subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib (LENVIMA®), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA®), Merck's anti-PD-1 therapy, versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (aRCC) (NCT02811861; Abstract: #364).

Key Points: 
  • We look forward to engaging in critical scientific exchange to improve outcomes for these patients."
  • A network meta-analysis to assess the efficacy of lenvatinib plus pembrolizumab compared with other first-line treatment options for patients with aRCC will be shared in a poster session (Abstract: #482).
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • These abstracts will be made available via the ASCO website on Monday, January 22, 2024, at 5:00 PM EST (2:00 PM PST).

Eisai Furthers Oncology Research Across Multiple Cancers at ASCO GI and ASCO GU 2024

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Tuesday, January 16, 2024
MSD, PRISM, Renal cell carcinoma, Hypoxia, Patient, HCC, Research, Neoplasm, Meta-analysis, Oxidative stress, Rescue coordination centre, RCC, Merck & Co., ASCO, Cell lineage, Everolimus, Society, Pembrolizumab, Headquarters, FGFR2, Deep, Cholangiocarcinoma, Drug discovery, Hepatocellular carcinoma, Cancer, Food, Proteostasis, CBP, Safety, Abstract, Food and Drug Administration, FDA, Inflammation, CREB-binding protein, Biomarker, LEAP, TKI, Merck, Differentiable function, Pharmaceutical industry

TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.

Key Points: 
  • TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.
  • First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

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Friday, January 5, 2024
Marketing, Hypothyroidism, INN, Woman, Progression-free survival, Nausea, Syndrome, Heart, Cancer, Inflammation, Skull, Proteinuria, Anatomy, Cell division, IIA, Diarrhea, Fatigue, ATC, Capsule, Bleeding, Pancreas, RET, VEGF, FGFR, Cerebral edema, Neoplasm, Stroke, Enzyme, Liver failure, Safety, Kidney cancer, Arthralgia, Heart failure, Patient, Urine, Medical Subject Headings, Stomatitis, Immune system, Everolimus, International, Encephalopathy, Language, Somatic symptom disorder, Blood, Mouth, Catherine Disher, Select, Medicine, Vomiting, Pembrolizumab, Cholesterol, PDGF, Kidney failure, Weight loss, Headache, KIT, Brain, Acral lentiginous melanoma, Swelling, Hypoesthesia, Splenic infarction, Confusion, European Medicines Agency, RCC, Kidney, Growth, Sunitinib, Hypercholesterolemia, Rash, Medical device

Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kisplyx, lenvatinib, Date of authorisation: 25/08/2016, Revision: 21, Status: Authorised

HUTCHMED Announces that it has Completed Enrollment of a Phase II/III Trial of Fruquintinib in Combination with Sintilimab for Advanced Renal Cell Carcinoma in China

Retrieved on: 
Wednesday, December 13, 2023
Quality of life, Axitinib, Shanghai Cancer Center, Everolimus, RECIST, HKEX, Fudan University, Sintilimab, RCC, TTR, Patient, Safety, Pharmaceutical industry

HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“ HUTCHMED ”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.

Key Points: 
  • HONG KONG, Shanghai and FLORHAM Park, N.J., Dec. 12, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (Nasdaq/AIM:​HCM, HKEX:​13) (“ HUTCHMED ”) today announces that it has completed enrollment of its Phase II/III trial of fruquintinib in combination with sintilimab as second-line treatment for locally advanced or metastatic renal cell carcinoma (“RCC”) in China.
  • The study is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy for the second-line treatment of advanced RCC.
  • The primary endpoint is progression free survival (“PFS”) per RECIST 1.1 as assessed by blinded independent central review (BICR).
  • If favorable, the results would enable a New Drug Application submission to China’s National Medical Products Administration (“NMPA”).

FDA Approves Merck’s WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF-TKI

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Friday, December 15, 2023
Biotechnology, General Health, FDA, Health, Pharmaceutical, MSD, Medicine, DSM-IV codes, PD-L1, NYSE, Potassium, Food, Progression-free survival, RECIST, Merck & Co., Head, Pneumonia, Blood transfusion, Dana–Farber Cancer Institute, Risk, Lymphocyte, Hypoxia, Everolimus, Bleeding, IMDC, Fatigue, Sepsis, Patient, Pregnancy, PFS, Effectiveness, Belzutifan, Week, VHL, VEGF, RCC, COVID-19, PD-1, Creatinine, TKI, ORR, Harvard Medical School, Death, Anemia, Fatal, Sodium, Hospital, Pleural effusion, HIV disease progression rates, MRK, Pharmaceutical industry, Birth control, Merck

Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.

Key Points: 
  • Also, WELIREG showed an objective response rate (ORR) of 22% (n=82) (95% CI, 18-27) versus 4% (n=13) (95% CI, 2-6) for everolimus.
  • Patients could have received up to three prior treatment regimens and were required to have measurable disease per RECIST v1.1.
  • Dose reductions of WELIREG due to an adverse reaction occurred in 13% of patients.
  • Adverse reactions that required dose reduction in ≥1% of patients were hypoxia (5%) and anemia (3.2%).

Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Diabetes, Infectious Diseases, Clinical Trials, Pharmaceutical, Cardiology, Medicine, Observation, Research, Safety, Therapy, Toxicity, Cohort, University, Everolimus, Learning, Brain, Patient, Ribociclib, Division, Pharmacokinetics, Hematology, Neutropenia, Diarrhea, Nausea, Cancer, Financial toxicity, Menarini, Traffic barrier, Pharmaceutical industry, MD

Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.

Key Points: 
  • Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.
  • Data was presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • The ELEVATE study is evaluating elacestrant in combination with inhibitors of the PI3K/AKT/mTOR pathway (everolimus and alpelisib) and cell-cycle pathway inhibitors (palbociclib, ribociclib, and abemaciclib).
  • Additional cohorts are currently under evaluation to assess pharmacokinetics (PK) and determine the recommended phase 2 dose (RP2D) for each combination.