European Society for Medical Oncology

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)

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Saturday, October 21, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, NYSE, ESMO, Progression-free survival, Congress, MRK, PFS, European Society for Medical Oncology, HIV disease progression rates, RCC, Risk, ORR, VEGFR, Patient, Death, Everolimus, Pharmaceutical industry, Merck

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).

ESMO 2023: Agenus’ Botensilimab/Balstilimab Combination Delivers Durable Responses across Multiple Sarcoma Subtypes

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Saturday, October 21, 2023
Science, Other Science, Biotechnology, Research, Oncology, General Health, Health, Other Health, Patient, University of Colorado School of Medicine, Pneumonitis, Hypophysitis, ESMO, Biomarker, Clinical research, Congress, European Society for Medical Oncology, BAL, MD, BOT, Inc., Cancer, Sarcoma, Immunotherapy, University, Anschutz Medical Campus, Leiomyosarcoma, Hepatitis, Safety, Myocarditis, Pharmaceutical industry, Medical imaging

The results were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023.

Key Points: 
  • The results were presented in an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2023.
  • Relapsed/refractory sarcoma represents a significant unmet medical need where existing standard of care options and previous immunotherapies have shown limited activity.
  • The sarcoma cohort presented is part of a larger phase 1b study evaluating the safety, efficacy, and dose optimization of BOT alone and in combination with BAL in multiple advanced solid tumors.
  • "Notably, we observed several durable responses extending past one year, including patients with visceral angiosarcoma, which is traditionally unresponsive to immunotherapy, as well as other cold subtypes like leiomyosarcoma.

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

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Friday, October 20, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Bevacizumab, Neoplasm, FDA, Arm, PD-L1, Standard of care, Cervical cancer, Gynaecology, Hypothyroidism, Catholic higher education, Aes, NYSE, ESMO, Progression-free survival, Food, Trae tha Truth, Cisplatin, Congress, Chemoradiotherapy, MRK, PFS, European Society for Medical Oncology, Obstetrics, GOG, Brachytherapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research, HIV disease progression rates, Creighton University School of Medicine, CPS, ClinicalTrials.gov, Merck & Co., Risk, EBRT, Immunotherapy, University, European Network for Health Technology Assessment, Woman, Safety, European Society of Gynaecological Oncology, Cancer, Patient, OS, Death, Pharmaceutical industry, Merck

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

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Friday, October 20, 2023
Pharmaceutical, Health, Oncology, Clinical Trials, MSD, Massachusetts General Hospital, Harvard Medical School, Cyclophosphamide, Aes, NYSE, ESMO, Epirubicin, Congress, Doxorubicin, MRK, European Society for Medical Oncology, PCR, Research, Neoadjuvant therapy, Paclitaxel, Neoplasm, Merck & Co., Myocardial infarction, Cancer, Recurrence, Breast cancer, Immunotherapy, EFS, European Society of Gynaecological Oncology, Patient, Death, Pharmaceutical industry, Medical imaging, Merck

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)

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Friday, October 20, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Survival, Neoplasm, FDA, Pemetrexed, PD-L1, McGill University Health Centre, SCLC, NSCLC, Aes, NYSE, ESMO, Food, Trae tha Truth, Lung cancer, Cisplatin, American Joint Committee on Cancer, Congress, Head, MRK, European Society for Medical Oncology, PCR, Carcinoma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Treatment of lung cancer, Research, Neoadjuvant therapy, Disease, Merck & Co., Risk, MPR, EFS, RECIST, Safety, AJCC, Cancer, European Society of Gynaecological Oncology, Patient, OS, Death, Associate, Pharmaceutical industry, Merck

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.

Detailed Results from Phase 3 CABINET Pivotal Trial Evaluating Cabozantinib in Advanced Neuroendocrine Tumors Presented at ESMO 2023

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Sunday, October 22, 2023
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Exelixis, National Institutes of Health, NCI, ESMO, Progression-free survival, Alliance for Clinical Trials in Oncology, Physician, Congress, PFS, European Society for Medical Oncology, Dana–Farber Cancer Institute, Glomus tumor, Data monitoring committee, Disease, NET, National Cancer Institute, Oncology, CET, NETS, EXEL, Pnet, Patient, Bangladesh Technical Education Board, DSMB, Pharmaceutical industry, Medical imaging, Carcinoid

Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib (CABOMETYX®) compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors (pNET) and a second cohort of patients with advanced extra-pancreatic NET (epNET).
  • “Although progress has been made in recent years, there remains a critical need for new and effective therapies for patients with advanced neuroendocrine tumors.
  • Results from the CABINET study presented today at ESMO demonstrate that treatment with cabozantinib resulted in compelling improvements in PFS based both on local review and on independent blinded central radiology review.
  • The safety profile of cabozantinib observed in each cohort was consistent with its known safety profile; no new safety signals were identified.

New Research from Foundation Medicine and Roche Demonstrates Improved Outcomes Following Treatment Based on Comprehensive Genomic Profiling in Patients with Cancer of Unknown Primary Origin (CUP)

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Friday, October 20, 2023
Biotechnology, Genetics, Health, Oncology, Neoplasm, Patient, Survival, FDA, ESMO, Food, Progression-free survival, CGP, CUP, European Society for Medical Oncology, Foundation Medicine, MD, Doctor of Philosophy, Research, Liquid, Radiation, Roche, Safety, Cancer, Diagnosis, Pharmaceutical industry

These patients have a high unmet medical need due to the lack of a definitive diagnosis of a primary tumor site.

Key Points: 
  • These patients have a high unmet medical need due to the lack of a definitive diagnosis of a primary tumor site.
  • Because the cancer’s tumor of origin is unknown, targeted treatment has historically been challenging.
  • “Patients with CUP do not have many treatment options, so we set out to investigate how implementing comprehensive genomic profiling could impact outcomes,” said Dr. Jeffrey Ross, Medical Director at Foundation Medicine.
  • Patients achieving disease control were randomized 3:1 to targeted therapy informed by comprehensive genomic profiling versus chemotherapy continuation for at least three further cycles.

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

Retrieved on: 
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.

Bicara Therapeutics Presents Updated Interim Data from Ongoing Phase 1/1b Study of BCA101 in 1L HPV-negative Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) at ESMO Congress 2023

Retrieved on: 
Monday, October 23, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, PD-L1, ESMO, Pembrolizumab, HPV, Congress, Head, European Society for Medical Oncology, HNSCC, CPS, Neoplasm, ORR, Therapy, Patient, Vaccine, Pharmaceutical industry

“We are excited to showcase these updated Phase 1/1b data at ESMO, which continue to demonstrate a significant response rate and underscore the potential of BCA101 as a new treatment option for HPV-negative R/M HNSCC,” said David Raben, M.D., chief medical officer of Bicara Therapeutics.

Key Points: 
  • “We are excited to showcase these updated Phase 1/1b data at ESMO, which continue to demonstrate a significant response rate and underscore the potential of BCA101 as a new treatment option for HPV-negative R/M HNSCC,” said David Raben, M.D., chief medical officer of Bicara Therapeutics.
  • “This is a very difficult population to treat and patients are in desperate need of new therapeutic options.
  • 46% ORR in total evaluable study population including the 11 HPV-positive patients.
  • Title: Dose expansion results of the bifunctional EGFR/TGFβ inhibitor BCA101 with pembrolizumab in patients with recurrent, metastatic head and neck squamous cell carcinoma

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

Retrieved on: 
Friday, October 20, 2023
Research, FDA, Clinical Trials, Stem Cells, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, MSD, TKI, DXD, NSCLC, SCLC, Cleavage, NYSE, ESMO, Food, Breakthrough therapy, Congress, MRK, European Society for Medical Oncology, Conference, GAAP, Regulation of tobacco by the U.S. Food and Drug Administration, HIV disease progression rates, Journal, Trastuzumab deruxtecan, ADC, Daiichi Sankyo, EPS, TSE, Spacecraft, American Journal of Clinical Oncology, Lung cancer, Cancer, Patient, BLA, Fine chemical, Pharmaceutical industry, Merck, Limited

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.