Merck

Merck’s WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

Retrieved on: 
Saturday, October 21, 2023
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Treatment-related adverse events (TRAEs) occurred in 89% of patients who received WELIREG (n=331) versus 89.4% of patients who received everolimus (n=322).

Key Points: 
  • Treatment-related adverse events (TRAEs) occurred in 89% of patients who received WELIREG (n=331) versus 89.4% of patients who received everolimus (n=322).
  • Grade ≥3 TRAEs occurred in 38.7% of patients who received WELIREG versus 39.4% of patients who received everolimus.
  • Adverse events led to discontinuation of study treatment in 5.9% of patients who received WELIREG and 14.7% who received everolimus.
  • Treatment-related adverse events led to death in 0.3% of patients who received WELIREG (n=1) and 0.6% of patients who received everolimus (n=2).

Merck’s KEYTRUDA® (pembrolizumab) Plus Concurrent Chemoradiotherapy Significantly Improved Progression-Free Survival (PFS) Versus Concurrent Chemoradiotherapy Alone in Newly Diagnosed, High-Risk Locally Advanced Cervical Cancer

Retrieved on: 
Friday, October 20, 2023
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Results from the trial showed that KEYTRUDA in combination with concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to concurrent chemoradiotherapy alone for these patients.

Key Points: 
  • Results from the trial showed that KEYTRUDA in combination with concurrent chemoradiotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to concurrent chemoradiotherapy alone for these patients.
  • ET during a late-breaking abstract proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2023 (abstract #LBA38).
  • After a median follow-up of 17.9 months (range, 0.9-31.0), the KEYTRUDA regimen reduced the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.55-0.89]; p=0.0020) versus concurrent chemoradiotherapy alone in these patients.
  • The 24-month PFS rate was 67.8% for patients who received the KEYTRUDA regimen compared to 57.3% for those who received concurrent chemoradiotherapy alone.

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Improvement in Pathological Complete Response (pCR) Rate as Neoadjuvant Therapy Versus Chemotherapy in High-Risk, Early-Stage ER+/HER2- Breast Cancer

Retrieved on: 
Friday, October 20, 2023
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KEYTRUDA plus chemotherapy before surgery met one of its dual primary endpoints of pathological complete response (pCR), demonstrating a statistically significant improvement in pCR rate compared to placebo plus chemotherapy.

Key Points: 
  • KEYTRUDA plus chemotherapy before surgery met one of its dual primary endpoints of pathological complete response (pCR), demonstrating a statistically significant improvement in pCR rate compared to placebo plus chemotherapy.
  • The pCR rate increased from 15.6% in patients treated with neoadjuvant chemotherapy alone (n=100/643) to 24.3% in patients treated with neoadjuvant KEYTRUDA plus chemotherapy (n=154/635), an estimated increase of 8.5 percentage points (p=0.00005).
  • A pCR rate is defined as a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery (ypT0/Tis ypN0).
  • Treatment-related AEs in the neoadjuvant part of the study that led to discontinuation of any drug occurred in 19.1% of patients treated with KEYTRUDA plus chemotherapy and 10.1% who received chemotherapy.

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as Single Agent After Surgery Reduced Risk of Death by 28% Versus Pre-Operative Chemotherapy in Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Friday, October 20, 2023
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The 36-month OS rates were 71.3% for patients who received the KEYTRUDA-based regimen versus 64.0% for patients who received the chemotherapy-placebo regimen.

Key Points: 
  • The 36-month OS rates were 71.3% for patients who received the KEYTRUDA-based regimen versus 64.0% for patients who received the chemotherapy-placebo regimen.
  • The 36-month EFS rates were 54.3% for patients who received the KEYTRUDA-based regimen versus 35.4% for patients who received the chemotherapy-placebo regimen.
  • “The results of KEYNOTE-671 represent an important milestone in our fight to improve treatment outcomes for patients with surgically resectable non-small cell lung cancer.
  • “Non-small cell lung cancer is the leading cause of cancer-related death worldwide and this new regimen applies to a wide range of surgically resectable patients.

KEYTRUDA® (pembrolizumab) Plus Trastuzumab and Chemotherapy Significantly Improved Progression-Free Survival (PFS) Versus Trastuzumab and Chemotherapy in First-Line HER2-Positive Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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Friday, October 20, 2023
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Based on a pre-specified subgroup analysis, the improvement in PFS observed in the ITT population was limited to patients whose tumors expressed PD-L1 (CPS ≥1).

Key Points: 
  • Based on a pre-specified subgroup analysis, the improvement in PFS observed in the ITT population was limited to patients whose tumors expressed PD-L1 (CPS ≥1).
  • In the study, more than 80% of patients’ tumors expressed PD-L1 (CPS ≥1).
  • The most common of these events (occurring in ≥10% of patients) were infusion reactions (16.6%) and hypothyroidism (10.3%).
  • Immune-mediated AEs and infusion reactions that led to discontinuation of any study treatment occurred in 7% of patients receiving the KEYTRUDA regimen and 4% of patients receiving trastuzumab and chemotherapy alone.

Daiichi Sankyo and Merck Announce Global Development and Commercialization Collaboration for Three Daiichi Sankyo DXd ADCs

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Friday, October 20, 2023
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The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights.

Key Points: 
  • The companies will jointly develop and potentially commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights.
  • Merck also will pay Daiichi Sankyo up to an additional $5.5 billion for each DXd ADC contingent upon the achievement of certain sales milestones.
  • If Merck opts out of patritumab deruxtecan and/or raludotatug deruxtecan, the upfront payments already paid will be retained by Daiichi Sankyo and rights related to such DXd ADCs will be returned to Daiichi Sankyo.
  • The collaboration is expected to contribute to enhancing the corporate and shareholder value of Daiichi Sankyo over the medium to long term.

Government of Serbia and Ginkgo Bioworks Announce Bioeconomy Collaboration in BIO4 Campus

Retrieved on: 
Thursday, October 19, 2023
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The BIO4 campus initiative already gathers more than 1,000 PhD scientists from 17 scientific institutions, and the campus itself will open in 2026.

Key Points: 
  • The BIO4 campus initiative already gathers more than 1,000 PhD scientists from 17 scientific institutions, and the campus itself will open in 2026.
  • Within the envisioned collaboration, companies on the BIO4 campus will have the opportunity to take advantage of incentives to access Ginkgo's platform.
  • Further, under the MoU, Ginkgo and the Government of Serbia will also explore partnerships to develop and implement new biomonitoring capabilities in Serbia.
  • The Centre is part of the C4IR network, and co-founded by the World Economic Forum and the Government of Serbia.

USA Health Children's & Women's Hospital Goes Live with AdaptX for Maternal Health Equity Initiative

Retrieved on: 
Thursday, October 19, 2023
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SEATTLE, Oct. 19, 2023 /PRNewswire-PRWeb/ -- AdaptX®, a self-serve clinical management solution company, today announced the go-live of Alabama-based USA Health Children's and Women's Hospital with AdaptX's Obstetrics Advisor™ solution to improve maternal health equity, in partnership with the Institute of Healthcare Improvement (IHI) and with generous support from Merck for Mothers.

Key Points: 
  • "AdaptX is transforming the way we approach maternal health equity," said Vicki Curtis, MSN, RN, RNC-OB, director of women's services for USA Health Children's and Women's Hospital.
  • As part of this innovative maternal health initiative, USA Health Children's & Women's Hospital is receiving unique change management training and support from the IHI's quality improvement experts, reflecting the IHI's commitment to improving health equity.
  • I'm hopeful that this partnership and approach will show practical solutions that will close maternal health equity gaps."
  • "The AdaptX team is honored to partner with USA Health and the IHI to improve maternal health equity," said Warren Ratliff, chief executive officer of AdaptX.

Genascence Names Ian Lachlan McLean, M.D. Ph.D. as Chief Medical Officer

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Wednesday, October 18, 2023
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PALO ALTO, Calif., Oct. 18, 2023 /PRNewswire/ -- Genascence Corporation ("Genascence"), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, today announced the appointment of Ian Lachlan (Lachy) McLean, M.D., Ph.D. as its chief medical officer. Dr. McLean brings extensive leadership experience in both early and late-stage clinical research and development (R&D) in the biopharmaceutical space, as well as complimentary clinical practice expertise as a rheumatologist to Genascence. He will lead Genascence's clinical development strategy.

Key Points: 
  • —Seasoned physician-scientist and R&D executive, with significant experience building and growing successful clinical development organizations—
    PALO ALTO, Calif., Oct. 18, 2023 /PRNewswire/ -- Genascence Corporation ("Genascence"), a clinical-stage biotechnology company revolutionizing the treatment of prevalent musculoskeletal diseases with gene therapy, today announced the appointment of Ian Lachlan (Lachy) McLean, M.D., Ph.D. as its chief medical officer.
  • "On behalf of the entire Genascence organization and board of directors, I am thrilled to welcome Lachy as our chief medical officer," said Thomas Chalberg, Ph.D., founder and CEO of Genascence.
  • "Genascence is at the forefront of transforming how we treat prevalent and debilitating musculoskeletal diseases like osteoarthritis with gene therapy," said Dr. McLean.
  • Before joining Genascence, Dr. McLean was chief medical officer at Novome, a start-up biotech company developing engineered bacteria as a drug-delivery platform.

Olema Oncology Appoints Oncology Biotech Executive Scott Garland to Board of Directors

Retrieved on: 
Tuesday, October 17, 2023
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SAN FRANCISCO, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ( “Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced the appointment of Scott Garland to the company’s Board of Directors.

Key Points: 
  • SAN FRANCISCO, Oct. 17, 2023 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. ( “Olema” or “Olema Oncology,” Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today announced the appointment of Scott Garland to the company’s Board of Directors.
  • Mr. Garland brings more than 30 years of biopharmaceutical industry experience with deep commercial and executive leadership expertise.
  • “We are delighted to have Scott join our Board of Directors at such an exciting time for Olema,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology.
  • Mr. Garland currently serves as a board member for ALX Oncology and Day One Biopharmaceuticals.