Avutometinib

Verastem Oncology Outlines Key 2024 Strategic Priorities and Upcoming Catalysts for Advancing Avutometinib and Defactinib and Broader Pipeline in RAS Pathway-Driven Cancers

Retrieved on: 
Monday, January 29, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Verastem Oncology, Patient, Accelerated approval (FDA), Toxicology, GLP, BIW, Part, Diagnosis, Safety, RAMP, Cancer, NSCLC, IND, Food, NDA, RAS, Lung cancer, FDA, Avutometinib, QD, Pancreatic cancer, Pharmaceutical industry

Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today outlined key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers.

Key Points: 
  • Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today outlined key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers.
  • “We have made significant progress in our commitment to advancing new solutions for RAS pathway-driven cancers and look forward to an exciting and catalyst-filled year ahead.
  • Safety and tolerability continued to be favorable and consistent with previously reported data.
  • Entered into a discovery and development collaboration with GenFleet Therapeutics (“GenFleet”) to advance three oncology discovery programs targeting RAS pathway-driven cancers.

Verastem Oncology Granted Fast Track Designation for Combination of Avutometinib and Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, January 18, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Neoplasm, Verastem Oncology, Patient, Therapy, MAPK, DLT, AACR, RAMP, Cancer, Mutation, Food, Conference, Safety, FDA, Toxicity, ERK, Avutometinib, RAS, Pharmaceutical industry

“Receiving Fast Track Designation for the combination of avutometinib and sotorasib reinforces the importance of improving the depth of MAPK pathway inhibition to enhance tumor regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC,” said Dan Paterson, President and CEO, Verastem Oncology.

Key Points: 
  • “Receiving Fast Track Designation for the combination of avutometinib and sotorasib reinforces the importance of improving the depth of MAPK pathway inhibition to enhance tumor regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC,” said Dan Paterson, President and CEO, Verastem Oncology.
  • “Given that KRAS G12C is the most common KRAS mutation in NSCLC, the advancement of the combination is important in understanding potential new treatment approaches.
  • The pharmacokinetic profile of avutometinib in combination with sotorasib in the RAMP 203 trial was similar to results in monotherapy studies.
  • These initial RAMP 203 results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October, 2023.

Verastem Oncology Announces Initiation of a Confirmatory Phase 3 Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Retrieved on: 
Wednesday, December 13, 2023
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“Patients and treating physicians have advocated for more research and development in support of LGSOC.

Key Points: 
  • “Patients and treating physicians have advocated for more research and development in support of LGSOC.
  • At Verastem Oncology, we are moving with urgency to offer a Phase 3 study specifically directed at this disease in an effort to address this need,” said Dan Paterson, President and Chief Executive Officer, Verastem Oncology.
  • RAMP 301 is a global trial with enrollment open in the U.S. and planned enrollment in Canada, the United Kingdom, Europe, Australia, and Korea.
  • Dr. Grisham and Dr. Banerjee are paid consultants for Verastem Oncology.

Verastem Oncology Strengthens Executive Leadership Team with Key Appointments

Retrieved on: 
Thursday, October 26, 2023
Science, Other Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Other Health, Bryant University, Manchester Metropolitan University, FDA, Roivant Sciences, RAS, Strategic planning, Kite Pharma, Food, Accounting, Rare, Johns Hopkins University, Johns, PwC, Investigational New Drug, European Medicines Agency, Biologics license application, Global marketing, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Senior, Avutometinib, Celgene, Bachelor of Science, LLP, Regulation, Verastem Oncology, Assurance, Marketing, Head, Lead, Quality, Cancer, AbbVie, Patient, Consultant, MS, Regulatory affairs, Pharmaceutical industry, Management, Finance, Chemistry, Drug discovery

"These leadership appointments bring significant experience in oncology regulatory and commercial success as well as deep financial expertise as we move to the next stage of the Company’s development.

Key Points: 
  • "These leadership appointments bring significant experience in oncology regulatory and commercial success as well as deep financial expertise as we move to the next stage of the Company’s development.
  • This includes filing for accelerated approval for avutometinib and defactinib in LGSOC and preparing for a commercial launch of this potential first FDA-approved medicine for this patient population," stated Dan Paterson, President and Chief Executive Officer of Verastem Oncology.
  • "This strengthened executive team, combined with Verastem’s significant progress in advancing therapies across RAS pathway-driven cancers, is expected to accelerate our work to bring new therapies to patients with high unmet medical need."
  • Dan Calkins, Chief Financial Officer, joined Verastem Oncology in 2018 and has served as Vice President of Finance since September 2022.

Verastem Oncology Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, August 8, 2023
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Topotecan, Pancreatic cancer, KRAS, Verastem Oncology, Avutometinib, Table, BIW, Pancreatic Cancer Action Network, Bank statement, General Administration of Press and Publication, Pancreas, Cancer, Paclitaxel, Anastrozole, GAAP, SOC, NSCLC, FRAME, Lung cancer, PFS, RAMP, Acquisition, HIV disease progression rates, RAS, Patient, Standard of care, Investment, European Society of Gynaecological Oncology, GOG, European Network of Transmission System Operators for Electricity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Research and development, Society, Breakthrough, ORR, Letrozole, Food, Safety, Pharmaceutical industry, Transformer

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the second quarter ending June 30, 2023 and highlighted recent progress.
  • Verastem Oncology ended the second quarter of 2023 with cash, cash equivalents and investments of $183.1 million.
  • Research & development expenses for the 2023 Quarter were $12.9 million, compared to $14.9 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $7.4 million, compared to $6.5 million for the 2022 Quarter.

Verastem Oncology Announces Promotion of Dan Paterson to Chief Executive Officer

Retrieved on: 
Tuesday, July 11, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Verastem Oncology, Avutometinib, Cancer, Breakthrough therapy, Retirement, Acquisition, RAS, Patient, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Management, Nursing

Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today that Dan Paterson, President and Chief Operating Officer, has been promoted to President and Chief Executive Officer (CEO).

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM) (the “Company”), a biopharmaceutical company committed to advancing new medicines for patients with cancer, announced today that Dan Paterson, President and Chief Operating Officer, has been promoted to President and Chief Executive Officer (CEO).
  • We are pleased to announce this well-deserved promotion to Chief Executive Officer.”
    Dan Paterson joined Verastem Oncology in 2011 and has served as Chief Operating Officer since 2014 and President since 2019.
  • At Verastem Oncology, he spearheaded the acquisition of lead compound avutometinib and strategic direction to accelerate the program’s advancement.
  • “I am energized to build on the accomplishments we have made as a management team and to lead Verastem Oncology forward in establishing avutometinib as a backbone therapy for RAS pathway-driven tumors,” said Dan Paterson.

Verastem Oncology Announces Design for Confirmatory Trial of Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Retrieved on: 
Wednesday, July 5, 2023
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RAMP 301, a randomized global confirmatory trial, will evaluate the efficacy and safety of avutometinib and defactinib versus standard of care (SOC) chemotherapy and hormonal therapy in patients with recurrent LGSOC.

Key Points: 
  • RAMP 301, a randomized global confirmatory trial, will evaluate the efficacy and safety of avutometinib and defactinib versus standard of care (SOC) chemotherapy and hormonal therapy in patients with recurrent LGSOC.
  • RAMP 301 is the follow-up confirmatory study for full approval in recurrent LGSOC.
  • The RAMP 301 trial will be led globally and in the U.S. by Rachel Grisham, MD, Section Head, Ovarian Cancer and Director, Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center in Westchester, NY.
  • Dr. Banerjee and Dr. Grisham have consulting relationships with Verastem Oncology.

Updated Data from Part A of Verastem Oncology's RAMP 201 Trial Show an Objective Response Rate of 45% in Patients with Recurrent Low-Grade Serous Ovarian Cancer Treated with Avutometinib and Defactinib

Retrieved on: 
Thursday, May 25, 2023
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In the RAMP 201 study, treatment with the combination of avutometinib and defactinib resulted in an objective response rate (ORR) of 45% (13/29) and tumor shrinkage in 86% (25/29) of evaluable patients.

Key Points: 
  • In the RAMP 201 study, treatment with the combination of avutometinib and defactinib resulted in an objective response rate (ORR) of 45% (13/29) and tumor shrinkage in 86% (25/29) of evaluable patients.
  • RAMP 201 is an international registration-directed Phase 2 study evaluating the safety and efficacy of avutometinib (VS-6766) alone and in combination with defactinib among patients with recurrent LGSOC.
  • The discontinuation rate, due to ≥ 1 adverse event, was 12% in the trial overall to date (4.9% due to elevated blood CPK).
  • These results indicate that the combination of avutometinib and defactinib shows promise as a tolerable treatment with impressive response rates for women with recurrent LGSOC.

Verastem Oncology Reports First Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, May 9, 2023
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Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the first quarter ending March 31, 2023, and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the first quarter ending March 31, 2023, and highlighted recent progress.
  • Verastem Oncology ended the first quarter of 2023 with cash, cash equivalents and investments of $111.2 million.
  • Research & development expenses for the 2023 Quarter were $12.0 million, compared to $13.6 million for the 2022 Quarter.
  • Selling, general & administrative expenses for the 2023 Quarter were $7.3 million, compared to $5.9 million for the 2022 Quarter.

New Data from Interim Analysis of Verastem Oncology’s RAMP 201 Trial Evaluating Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer to be Presented at the American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Wednesday, April 26, 2023
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The efficacy and safety of each regimen were assessed in both KRAS mutant and KRAS wild-type recurrent LGSOC.

Key Points: 
  • The efficacy and safety of each regimen were assessed in both KRAS mutant and KRAS wild-type recurrent LGSOC.
  • The ongoing expansion Phase of the trial, which is fully enrolled, will evaluate the efficacy and safety of the regimen selected.
  • “LGSOC is a difficult disease to treat and one in need of improved therapies to address this unique ovarian cancer.
  • Details for the ASCO 2023 Annual Meeting presentation are as follows:
    Title: Initial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC).