Vinorelbine

Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated metastatic HR-positive, HER2-negative breast cancer

Retrieved on: 
Tuesday, April 2, 2024

The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.

Key Points: 
  • The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
  • Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
  • A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple-negative breast cancer (TNBC) and HR-positive, HER2-negative breast cancer.
  • Comparative Overall Survival of CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy Alone for Hormone receptor-positive, HER2-negative metastatic breast cancer.

LOTUS REPORTS ITS BEST QUARTER EVER WITH THE BIGGEST LAUNCH IN ITS HISTORY

Retrieved on: 
Friday, November 11, 2022

Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.

Key Points: 
  • Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.
  • Consolidated net sales were NT$5,389 million, representing a growth of 85.2% over the last quarter and 76.3% versus prior year period.
  • Sales from Export increased 245% compared to last quarter and 183% compared to same period last year.
  • Asian Business continued to grow for the third consecutive quarter, 3.2% over last quarter, also 10.8% over the same period last year.

LOTUS REPORTS ITS BEST QUARTER EVER WITH THE BIGGEST LAUNCH IN ITS HISTORY

Retrieved on: 
Friday, November 11, 2022

Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.

Key Points: 
  • Third quarter 2022 is the best quarter ever in the Company's history, majorly driven by the successful launch of Lenalidomide in the US the biggest launch in Lotus history so far.
  • Consolidated net sales were NT$5,389 million, representing a growth of 85.2% over the last quarter and 76.3% versus prior year period.
  • Sales from Export increased 245% compared to last quarter and 183% compared to same period last year.
  • Asian Business continued to grow for the third consecutive quarter, 3.2% over last quarter, also 10.8% over the same period last year.

Eisai Presents Results of Post Hoc Analysis of Eribulin Mesylate (HALAVEN) at the European Society for Medical Oncology (ESMO) Congress 2022

Retrieved on: 
Monday, September 12, 2022

These data were presented as a poster (Presentation: #259P) at the European Society for Medical Oncology (ESMO) Annual Meeting (#ESMO22), held virtually and in-person in Paris, France from September 9-13, 2022.

Key Points: 
  • These data were presented as a poster (Presentation: #259P) at the European Society for Medical Oncology (ESMO) Annual Meeting (#ESMO22), held virtually and in-person in Paris, France from September 9-13, 2022.
  • HER2-low tumors express low amounts of the HER2 protein, but not enough to be considered HER2-positive.
  • HER2-low is defined as an IHC of 1+ or 2 with a negative ISH.
  • Of those patients, about 60% would now be considered to have the HER2-low subtype.

Eisai Presents New Data From its Oncology Portfolio and Pipeline at ESMO Congress 2022

Retrieved on: 
Tuesday, September 6, 2022

TOKYO, Sept 6, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place virtually and in-person in Paris, France from September 9 to 13.

Key Points: 
  • TOKYO, Sept 6, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2022, which is taking place virtually and in-person in Paris, France from September 9 to 13.
  • The study evaluated the combination of lenvatinib plus anti-PD-1 antibody pembrolizumab from Merck & Co., Inc., Rahway, NJ, USA versus lenvatinib monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma.
  • To date, more than 15 trials have been initiated under the LEAP clinical program, which is evaluating the combination across multiple tumor types.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

SELLAS Life Sciences Reports Encouraging Updated Clinical Data Indicating Increased Survival from Ongoing Phase 1 Mesothelioma Study of Galinpepimut-S Combined with Opdivo

Retrieved on: 
Wednesday, June 8, 2022

Data from eight patients enrolled in the study have been analyzed, with final data in the clinical trial expected by the end of 2022.

Key Points: 
  • Data from eight patients enrolled in the study have been analyzed, with final data in the clinical trial expected by the end of 2022.
  • The study details are as follows:
    Of the eight evaluable patients, six were male and two were female, with the median age of 66.
  • 75 percent of the patients entered the study as Stage III or IV patients, with 50 percent of patients entering as Stage IV.
  • Initial tumor stages were II (two patients), III and IIIB (two patients) and IV (four patients).

Promising Developments in Breast Cancer Treatments Ahead in 2022

Retrieved on: 
Wednesday, January 12, 2022

VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .

Key Points: 
  • VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .
  • There are plenty more developments to come from biotech companies working into 2022 on new treatments for breast cancer including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Illumina, Inc. (NASDAQ:ILMN), Zai Lab Limited (NASDAQ:ZLAB), Merus N.V. (NASDAQ:MRUS), and Veru Inc.(NASDAQ:VERU).
  • For breast cancer patients treated with pelareorep Oncolytics has witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- in IND-213as seen from study results delivered in 2017.
  • We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China."

Promising Developments in Breast Cancer Treatments Ahead in 2022

Retrieved on: 
Wednesday, January 12, 2022

VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .

Key Points: 
  • VANCOUVER, BC, Jan. 12, 2022 /PRNewswire/ -- USA News Group - So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis .
  • There are plenty more developments to come from biotech companies working into 2022 on new treatments for breast cancer including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Illumina, Inc. (NASDAQ:ILMN), Zai Lab Limited (NASDAQ:ZLAB), Merus N.V. (NASDAQ:MRUS), and Veru Inc.(NASDAQ:VERU).
  • For breast cancer patients treated with pelareorep Oncolytics has witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- in IND-213as seen from study results delivered in 2017.
  • We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China."

Merus Presents Updated Analysis of Zenocutuzumab, Trastuzumab, and Vinorelbine in Patients with HER2+ Metastatic Breast Cancer at the San Antonio Breast Cancer Symposium

Retrieved on: 
Friday, December 10, 2021

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 10, 2021 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), presented clinical data on zenocutuzumab (Zeno) in combination with trastuzumab and vinorelbine in patients (pts) with HER2 positive/amplified (HER2+) metastatic breast cancer (MBC) who had progressed on anti-HER2 antibody drug conjugates (ADC), at the San Antonio Breast Cancer Symposium in San Antonio, Texas.

Key Points: 
  • We are encouraged by Zenos potential to be active in indications outside NRG1 fusion cancers, opening opportunities for potential collaborations in these areas.
  • The reported data are from the completed phase 2 study, designed to explore the efficacy of a triplet combination of Zeno plus trastuzumab and vinorelbine in MBC patients (NCT03321981).
  • Preliminary results for patients treated with the triplet regimen were presented at the American Society of Clinical Oncology 2020 Annual Meeting.
  • The combination was observed to be well-tolerated in the run-in cohort and the cohort was expanded.

TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Retrieved on: 
Thursday, November 18, 2021

TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer.

Key Points: 
  • TROPION-Breast01 is the first pivotal trial of datopotamab deruxtecan in breast cancer and the third pivotal study in our clinical development program, underscoring our efforts to accelerate development of this TROP2 directed ADC in breast and lung cancer.
  • Most patients with HR positive, HER2 negative metastatic breast cancer will inevitably progress on available treatments, including hormonal therapy and standard of care chemotherapy.
  • The TROPION-Breast01 trial will evaluate whether datopotamab deruxtecan may be a more effective treatment than chemotherapy for patients with previously treated HR positive, HER2 negative advanced breast cancer previously treated with one to two lines of chemotherapy.
  • Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.