Last update 26 Dec 2024

Bevacizumab

Last update 26 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Bevacizumab(Genetical Recombination), rhuMAb-VEGF, 贝伐单抗

+ [17]

Target

VEGF-A

Mechanism

VEGF-A inhibitors(Vascular endothelial growth factor A inhibitors), Angiogenesis inhibitors

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [12]

Active Indication

Unresectable Hepatocellular CarcinomaHepatocellular CarcinomaRecurrent Glioblastoma+ [191]

Inactive Indication

Acidemia, IsovalericAcute Basophilic LeukemiaAcute Eosinophilic Leukemia+ [276]

Originator Organization

Genentech, Inc.

Active Organization

National Cancer InstituteRoche Pharma AGRoche Pharma (Schweiz) AG

+ [22]

Inactive Organization

Celgene Corp.

Sanofi

Pharma Mar SA

+ [16]

Drug Highest PhaseApproved

First Approval Date

US (26 Feb 2004),

Colonic CancerRectal Cancer

RegulationAccelerated Approval (US), Breakthrough Therapy (US), Orphan Drug (US)

Gene Sequence

Sequence Code 41632H

Source: *****

Sequence Code 41637L

Source: *****

3,024

Clinical Trials associated with Bevacizumab

NCT06393751 / Not yet recruitingPhase 1/2IIT

A Randomized Phase 1/2 Trial Evaluating the Addition of Tolinapant to Weekly Paclitaxel With or Without Bevacizumab in Patients With Recurrent Epithelial Ovarian Cancer

This phase I/II trial tests the safety, best dose and effectiveness of adding tolinapant (ASTX660) to paclitaxel with or without bevacizumab in treating patients with ovarian cancer that has come back after a period of improvement (recurrent). Tolinapant may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, that promote the growth of tumor cells and increase resistance to chemotherapy. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of tumor cells. Adding ASTX660 to paclitaxel with or without bevacizumab may be safe, tolerable and/or effective in treating patients with recurrent ovarian cancer.

Start Date02 May 2025

Sponsor / Collaborator

National Cancer Institute

NCT06607458 / Not yet recruitingPhase 2

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients with Refractory Metastatic Colorectal Cancer with Liver Dominant Disease

The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable. The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver. Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone.
Participants will:
* Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone
* Visit clinic at least every two weeks for checkups and tests
* Complete scans approximately every two months

Start Date01 May 2025

Sponsor / Collaborator

Delcath Systems, Inc.

NCT06311851 / Not yet recruitingPhase 1/2IIT

An Open-Label Pilot Study to Evaluate Efficacy and Safety of Bevacizumab Via Transarterial Chemoembolization (TACE) in Patients With Liver Metastases

Trans arterial chemoembolization (TACE) has emerged as a treatment option for chemotherapy-refractory diseases in Liver metastases. By delivering chemotherapy agents directly to the tumor site, TACE can maximize local drug concentrations and reduce systemic adverse reactions. Bevacizumab is a monoclonal antibody that functions as an angiogenesis inhibitor. It works by slowing the growth of new blood vessels by inhibiting vascular endothelial growth factor A (VEGF-A). The application of Bevacizumab during TACE has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy, and safety of the application of Bevacizumab during TACE in patients with Liver Metastases by designing an open, single-arm phase II clinical study.

Start Date01 Apr 2025

Sponsor / Collaborator-

100 Clinical Results associated with Bevacizumab

100 Translational Medicine associated with Bevacizumab

100 Patents (Medical) associated with Bevacizumab

21,018

Literatures (Medical) associated with Bevacizumab

01 Dec 2025·Journal of Gastrointestinal Cancer

Third- or Further-Line Treatment in Patients with MSS Type Metastatic Colorectal Cancer

Article

Author: Gou, Miaomiao ; Qian, Niansong ; Dai, Guanghai ; Zhang, Yong ; Wang, Zhikuan

BACKGROUND:

The survival benefit from later-line treatment for patients with metastatic colorectal cancer (mCRC) remains disappointing. Here, in a real-world study, we were aimed to evaluate which choice will affect the survival of mCRC patients after standard treatment in Chinese patients.

METHODS:

A total of 129 patients with refractory mCRC were involved in the study. They received targeted monotherapy or combined with chemo-agents or PD-1 inhibitor before death. Overall survival (OS) and progression-free survival (PFS) were reviewed and evaluated from clinical features and treatment options.

RESULTS:

Among the 129 patients, the median age was 56 years (25-81). The mOS from third-line was 12.5 months. OS of patients who treated with chemo plus targeted therapy group in third-line was shown to be superior to pd-1 inhibitor in combination with antiangiogenic agents or antiangiogenic monotherapy group (15.6 m vs. 10.5 m vs. 8.4 m, p < 0.05). Patients had received triplet-drugs (bevacizumab plus low-dose irinotecan and oxaliplatin) and had prolonged survival compared to those had not (21.3 m vs 10.3 m, p = 0.004). OS between patients who had immunotherapy history or not was not significantly different (p > 0.05). The mPFS was 3.5 months in patients who had administered with antiangiogenic targeted agents plus anti-pd-1 and 4.7 months in chemo plus targeted therapy group and 2.2 months in the other group. In the triplet drugs group, preliminary results showed that ORR was 13.3% and DCR was 80%. The median PFS was 5.1 m, and the median OS was 10.6 m.

CONCLUSIONS:

Triplet drugs resulted in significantly longer overall survival, and immunotherapy may have limited benefit in MSS type CRC patients.

01 Mar 2025·Journal of Clinical and Experimental Hepatology

Lenvatinib Maintenance Therapy After Complete Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma and Portal Vein Tumoral Thrombosis: Alternative Strategy in a Resource-limited Setting

Article

Author: Krishna, Pradeep ; Maidur, Rohit ; Nischay ; Patil, Chandrashekhar ; Raghavaiah, Suresh ; Channagiri, Adarsh ; Kumar, Pramod

01 Feb 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Submacular Hemorrhage Rates Following Anti-Vascular Endothelial Growth Factor Injections for Exudative Age-Related Macular Degeneration

Article

Author: Kaufmann, Gabriel T. ; Boucher, Nicholas ; Starr, Matthew R. ; Aggarwal, Nitika ; Kaufmann, Gabriel T ; Starr, Matthew R ; Sharma, Chakshu

PURPOSE:

To examine rates of submacular hemorrhage in patients undergoing anti-vascular endothelial growth factor (VEGF) injections, comparing rates between specific anti-VEGF agents.

DESIGN:

Retrospective clinical cohort study.

METHODS:

All patients in the database from January 2015 to November 2023 with a diagnosis of neovascular age-related macular degeneration and accompanying submacular hemorrhage (SMH). SMH prevalence and associated anti-VEGF injection type were analyzed in 140,915 eyes (of which 9107 had SMH) in a nationwide aggregated electronic health care database using chi-square test of proportion. Visual acuity (VA) data was assessed using 2-sample independent t-tests. The primary outcome was rate of SMH per injection type. Secondary datapoints examined were time between SMH diagnosis and last anti-VEGF injection, number of injections before SMH, treatment interval at time of SMH, VA before and at 12 months after SMH, eyes undergoing pars plana vitrectomy (PPV) within 30 days of SMH, and VA before PPV and at 12 months after PPV.

RESULTS:

The last injection type in eyes with SMH was bevacizumab in 3430 (37.8%) eyes, brolucizumab-dbll in 46 (0.51%) eyes, aflibercept in 3221 (35.4%) eyes. Ranibizumab in 2246 (24.7%) eyes, and faricimab-svoa in 155 (1.7%) eyes. Rates of SMH were significantly higher (P ≤ .001) for last injection with bevacizumab compared to every other injection type. Rates of SMH were significantly lower (P = .0004) for last injection with faricimab-svoa or ranibizumab injections each had significantly shorter (mean and standard deviation 48.9 (27.9), P < .02; mean and standard deviation 59.6 (38.2), P = .003, respectively) mean time between SMH diagnosis and last injection than did patients undergoing any other injection. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type among all patients. The number of patients who underwent PPV were 52 (1.51%) for bevacizumab, 4 (8.7%) for brolucizumab-dbll, 58 (1.8%) for aflibercept, 41 (1.8%) for ranibizumab, and 3 (1.9%) for faricimab-svoa. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type in patients undergoing PPV.

CONCLUSIONS:

Faricimab may be more protective than other anti-VEGF injections against SMH in patients with neovascular age-related macular degeneration.

1,213

News (Medical) associated with Bevacizumab

23 Dec 2024

·pipelinereview.com

Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite Instability–High or Mismatch Repair Deficient Metastatic Colorectal Cancer

Approval based on results of the Phase 3 CheckMate -8HW trial, in which the dual immunotherapy combination of Opdivo plus Yervoy demonstrated statistically significant and clinically meaningful reduction in the risk of disease progression or death compared to investigator’s choice of chemotherapy With this approval, Opdivo plus Yervoy is the first dual checkpoint inhibitor treatment approved in the European Union for the first-line treatment of MSI-H/dMMR mCRC PRINCETON, NJ, USA I December 23, 2024 I Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo ® (nivolumab) plus Yervoy ® (ipilimumab)for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). “Colorectal cancer is the second leading cause of cancer death in Europe and patients are in need of new treatment options that delay disease progression. Approximately 5-7% of metastatic colorectal cancer patients have MSI-H/dMMR tumors and these patients are less likely to benefit from conventional chemotherapy and typically have poor prognosis outcomes,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “The EC’s decision to approve Opdivo plus Yervoy represents a significant milestone for this patient population in the European Union and underscores our commitment to advancing treatment options.” The decision is based on results from the CheckMate -8HW trial, which were presented at medical congresses earlier this year. These data formed the basis for the Company’s application to the European Medicines Agency (EMA) . In the study, Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoint of progression-free survival (PFS) and reduced the risk of disease progression or death by 79% compared to the investigator’s choice of chemotherapy as assessed by Blinded Independent Central Review (BICR). The safety profile for the dual immunotherapy combination remained consistent with previously reported data and was manageable with established protocols, with no new safety signals identified. This approval by the EC for Opdivo plus Yervoy for the first-line treatment of adult patients with MSI-H or dMMR unresectable or mCRC is valid in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway. In addition to approval in colorectal cancer, Opdivo- based options are also approved for treatment of multiple tumor types in the EU. Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -8HW clinical trial. CheckMate -8HW and Select Efficacy and Safety Results With a median follow-up of approximately 31.5 months, CheckMate -8HW trial results showed: About CheckMate -8HW CheckMate -8HW (NCT04008030) is a Phase 3 randomized, open-label trial evaluating Opdivo plus Yervoy compared to Opdivo alone or the investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI with or without bevacizumab or cetuximab) in patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC). 839 patients were randomized to receive either Opdivo monotherapy ( Opdivo 240 mg Q2W for six doses, followed by Opdivo 480 mg Q4W), Opdivo plus Yervoy (Opdivo 240 mg plus Yervoy 1 mg/kg Q3W for four doses, followed by Opdivo 480 mg Q4W ), or investigator’s choice of chemotherapy. The dual primary endpoints of the trial are progression-free survival (PFS) per blinded independent central review (BICR) for Opdivo plus Yervoy compared to investigator’s choice of chemotherapy in the first-line setting and PFS per BICR for Opdivo plus Yervoy compared to Opdivo alone across all lines of therapy. Further data disclosure is planned at The American Society of Clinical Oncology Gastrointestinal Cancers Symposium taking place January 23, 2025, through January 25, 2025. The trial also evaluates several secondary safety and efficacy endpoints, including overall survival, which is ongoing. About dMMR or MSI-H Colorectal Cancer Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined. Mismatch repair deficiency (dMMR) occurs when the proteins that repair mismatch errors in DNA replication are missing or non-functional, leading to microsatellite instability-high (MSI-H) tumors. Approximately 5-7% of metastatic CRC patients have dMMR or MSI-H tumors. These patients are less likely to benefit from conventional chemotherapy and typically have a poor prognosis. Bristol Myers Squibb: Creating a Better Future for People with Cancer Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future. About Opdivo Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers. Opdivo ’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression. In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union. About Yervoy Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. INDICATIONS OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). OPDIVO® (nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® (nivolumab) as adjuvant treatment after surgery. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO® (nivolumab). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Please see US Full Prescribing Information for OPDIVO and YERVOY . Clinical Trials and Patient Populations Checkmate 227–previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 649–previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 238–adjuvant treatment of patients with completely resected Stage III or Stage IV melanoma; Checkmate 76K–adjuvant treatment of patients 12 years of age and older with completely resected Stage IIB or Stage IIC melanoma; Checkmate 274–adjuvant treatment of urothelial carcinoma; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Attraction-3–esophageal squamous cell carcinoma; Checkmate 648–previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma in combination with chemotherapy; Checkmate 648–previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma combination with YERVOY; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 816–neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 77T–Neoadjuvant treatment with platinum-doublet chemotherapy for non-small cell lung cancer followed by single-agent OPDIVO as adjuvant treatment after surgery; Checkmate 901–Adult patients with unresectable or metastatic urothelial carcinoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 205/039–classical Hodgkin lymph. About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , X (formerly Twitter), YouTube , Facebook and Instagram . SOURCE: Bristol Myers Squibb

Clinical ResultImmunotherapyDrug ApprovalPhase 3ASCO

23 Dec 2024

·www.globenewswire.com

Cara Therapeutics and Tvardi Therapeutics Announce Entry into Merger Agreement

Proposed Merger to create a Nasdaq-listed, clinical-stage biopharmaceutical company developing novel treatments targeting STAT3 to treat fibrosis-driven diseases Tvardi has recently completed an approximately $28 million private financing, which, together with Tvardi’s existing cash and Cara’s anticipated cash balance, is expected to fund the combined company into the second half of 2026 Tvardi anticipates reporting topline data in the second half of 2025 from two Phase 2 clinical programs utilizing its STAT3 inhibitor, TTI-101, including its lead program in idiopathic pulmonary fibrosis and its program in hepatocellular carcinoma Companies to host investor conference call and webcast today, December 18th, at 8:30am ET Dec. 18, 2024 -- Cara Therapeutics, Inc. (Nasdaq: CARA) and Tvardi Therapeutics, Inc. (“Tvardi”), a privately held, clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced that the companies have entered into a definitive merger agreement to combine in an all-stock transaction (the “Merger”). Under the terms of the agreement, Tvardi will merge with a wholly owned subsidiary of Cara. Upon completion of the Merger, pre-Merger Cara Therapeutics stockholders are expected to own approximately 17.0% of the combined company and pre-Merger Tvardi Therapeutics investors are expected to own approximately 83.0% of the combined company, in each case, prior to adjustment from the issuance of the shares in the recently completed Tvardi financing and assuming Cara has net cash at closing of between $22.875 million and $23.125 million. The percentage of the combined company that pre-merger Cara stockholders and pre-merger Tvardi stockholders will own upon the closing of the merger is subject to further adjustment if Cara’s net cash balance falls outside of the range. Upon completion of the Merger, the combined company is expected to operate under the name Tvardi Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “TVRD”. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi Therapeutics, stated, “As we approach meaningful value inflection points next year, including two Phase 2 readouts of our lead program in idiopathic pulmonary fibrosis, followed by the readout in our hepatocellular carcinoma program, this merger, the recently completed financing, and becoming a publicly traded company give us access to the critical funding required to further advance our promising pipeline programs that address significant unmet needs. I am grateful to the Cara Board, leadership team, and shareholders who share our vision of Tvardi that is well-positioned to introduce effective, new treatment options to patients suffering from serious, chronic, fibrosis-driven diseases.” “We are very excited to enter into this merger agreement with Tvardi and combine our financial resources with their expertise in STAT3 inhibition,” added Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “Our management and our Board of Directors thoroughly explored numerous strategic alternatives and believe that this merger with Tvardi is in the best interests of our stockholders and provides them with the opportunity to meaningfully participate in a company treating fibrosis-driven diseases in an innovative way.” Tvardi has recently completed an approximately $28 million private financing from a syndicate of new and existing institutional investors. With the cash from both companies at closing and the proceeds of this financing, the combined company is expected to have sufficient cash to fund its operating expenses and capital expenditure requirements into the second half of 2026, past the anticipated Phase 2 readouts in the second half of 2025. KORSUVA/KAPRUVIA Asset Sale Concurrent with the entry into the merger agreement with Tvardi, Cara also entered into an asset purchase agreement with Vifor Fresenius Medical Care Renal Pharma, Ltd. (“CSL Vifor”), a company jointly owned by Fresenius Medical Care and by the CSL Vifor business unit of the CSL Group. Pursuant to such asset purchase agreement, at the consummation of the transaction, Cara will sell to CSL Vifor and CSL Vifor will acquire from Cara certain assets and rights to the development, manufacture and commercialization of Korsuva®/Kapruvia® (difelikefalin) as well as certain associated liabilities (the “Asset Disposition”) for a purchase price of $900,000 (subject to certain adjustments with respect to inventory). Additionally, pursuant to the Asset Purchase Agreement, at the consummation of the Asset Disposition, Cara has agreed to pay CSL Vifor $3,000,000 to compensate CSL Vifor for the estimated incremental future expenses to be incurred by CSL Vifor as a result of the transfer of the assets to be acquired and the liabilities to be assumed by it in connection with the Asset Disposition. The Asset Disposition is subject to certain conditions to closing, including the consummation of the merger with Tvardi substantially contemporaneously with the Asset Disposition. Tvardi’s Pipeline of STAT3 Inhibitors The combined company will focus on advancing Tvardi’s pipeline of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need, including its lead candidate, TTI-101, which is in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF) and a Phase 1b/2 trial for hepatocellular carcinoma (HCC). STAT3 is a highly validated, yet historically undruggable, transcription factor, which is a central catalyst in fibrosis-driven diseases. TTI-101 is an orally bioavailable, small-molecule inhibitor of signal transducer and activator of transcription 3 (STAT3), a transcription factor whose upregulation and activation acts as a catalyst across critical pathways associated with fibrosis-driven diseases. TTI-101’s differentiated mechanism of action is designed to inhibit STAT3 to address the unmet need in fibrosis-driven diseases, without interfering with its other essential biological functions. TTI-101 has shown a robust pharmacokinetic profile, potency in inhibiting STAT3 activation and efficacy in animal models of fibrosis-driven diseases. In addition, in clinical trials performed to date, oral dosing with TTI-101 lowered levels of activated STAT3 in tumor tissue, was generally well-tolerated, and led to clinical responses in HCC and other tumor types. The REVERTIPF ongoing clinical trial is evaluating the safety and efficacy of TTI-101 alone or in addition to nintedanib (OFEV®) in patients suffering from IPF. The clinical trial is testing two different doses of TTI-101 compared to placebo using a Phase 2, randomized, double-blind, placebo-controlled design and is being conducted in the United States. Unblinded data from the REVERTIPF study is anticipated to be reported in the second half of 2025. ClinicalTrials.gov ID: NCT05671835 The REVERTLIVER CANCER ongoing clinical trial is evaluating the safety and efficacy of TTI-101 across three cohorts of patients with HCC: alone or in combination with standard of care treatments pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®) and bevacizumab (Avastin® or biosimilars Vegzelma®, Alymsys®, Zirabev®, and Mvasi®). The clinical trial is a Phase 1b/2 open-label study design being conducted in the United States. Preliminary topline data from the REVERTLIVER CANCER study is anticipated in the second half of 2025. ClinicalTrials.gov ID: NCT05440708 TTI-109, Tvardi’s second product candidate, is an oral, small-molecule, which is structurally related to, yet chemically distinct from, TTI-101 and is designed to enhance the ability to target STAT3. An IND application for TTI-109’s first human study is expected in the first half of 2025. Following the Merger, the combined company will be headquartered in Houston, Texas, and will be led by Tvardi’s CEO, Imran Alibhai, Ph.D., and other members of the Tvardi management team. The combined company's board of directors will be comprised of six directors from Tvardi’s Board of Directors and one director from Cara’s Board of Directors. The transaction has been approved by the Boards of Directors of both companies and is expected to close in the first half of 2025, subject to certain closing conditions, including, among other things, approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the SEC to register the shares of Tvardi common stock to be issued in connection with the Merger, Cara having a minimum amount of net cash as of the closing, and other customary closing conditions. In connection with the Merger, directors and officers of Cara and directors, officers and certain stockholders of Tvardi have executed support agreements, pursuant to which they have agreed to vote all their shares of capital stock in favor of the Merger. Tvardi is a privately held, clinical-stage, biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cara Therapeutics is a development-stage biopharmaceutical company that was leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. In connection with the proposed transaction between Cara and Tvardi, Cara intends to file relevant materials with the SEC, including a registration statement on Form S-4 that will contain a proxy statement and prospectus. CARA URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT CARA, TVARDI, THE PROPOSED TRANSACTION AND RELATED MATTERS. Stockholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Cara with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, stockholders will be able to obtain free copies of the proxy statement, prospectus and other documents filed by Cara with the SEC by contacting Investor Relations by email at investor@caratherapeutics.com. Stockholders are urged to read the proxy statement, prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. Cara and Tvardi, and each of their respective directors and executive officers and certain of their other members of management and employees, may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Cara’s directors and executive officers, consisting of Helen M. Boudreau, Jeffrey L. Ives, Ph.D., Christopher Posner, Susan Shiff, Ph.D., Martin Vogelbaum, Lisa von Moltke, M.D., Ryan Maynard and Scott Terrillion, including a description of their interests in Cara, by security holdings or otherwise, can be found under the captions, “Security Ownership of Certain Beneficial Owners and Management,” “Executive Compensation” and “Director Compensation” contained in the definitive proxy statement on Schedule 14A for Cara’s 2024 annual meeting of stockholders, filed with the SEC on April 22, 2024 (the “2024 Cara Proxy Statement”). To the extent that Cara’s directors and executive officers and their respective affiliates have acquired or disposed of security holdings since the applicable “as of” date disclosed in the 2024 Cara Proxy Statement, such transactions have been or will be reflected on Statements of Change in Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the persons who may be deemed participants in the proxy solicitation, including the information about the directors and executive officers of Tvardi, and a description of their direct and indirect interests, by security holdings or otherwise, will also be included in a registration statement filed on Form S-4 that will contain a proxy statement (and prospectus and other relevant materials) to be filed with the SEC when they become available. Investors should read the registration statement, proxy statement/prospectus and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction. These documents can be obtained free of charge from the sources indicated above. The content above comes from the network. if any infringement, please contact us to modify.

Acquisition

23 Dec 2024

·pmlive.com

Pfizer’s Braftovi regimen receives FDA accelerated approval to treat colorectal cancer

Pfizer’s Braftovi (encorafenib) regimen has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat metastatic colorectal cancer (mCRC). The drug has been authorised for use in combination with Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) to treat mCRC in patients with a BRAF V600E mutation. Until now, there were no approved biomarker-driven therapies specifically indicated for patients with previously untreated BRAF V600E-mutant mCRC. Colorectal cancer is the third most common type of cancer globally, with approximately 1.8 million new cases of the disease diagnosed in 2022. BRAF mutations are estimated to occur in up to 10% of patients with metastatic cases of the disease and are associated with a poor prognosis. Braftovi is an oral small molecule kinase inhibitor designed to target the most common BRAF mutation, BRAF V600E. Pfizer has exclusive rights to the drug in the US, Canada, Latin America, the Middle East and Africa, while licences are also held by Ono Pharmaceutical, Medison and Pierre Fabre. The FDA’s decision was supported by phase 3 results from the ongoing BREAKWATER trial in previously untreated mCRC patients with a BRAF V600E mutation. The Braftovi regimen was associated with a statistically significant improvement over standard of care in one of the dual primary endpoints of confirmed overall response rate (ORR), with an ORR of 61% for Braftovi in combination with Erbitux and mFOLFOX6 versus 40% for chemotherapy, with or without bevacizumab. The median duration of response was 13.9 months for the Braftovi combination regimen versus 11.1 months for chemotherapy, and the safety profile of the regimen was consistent with the known safety profile of each respective agent. Chris Boshoff, chief oncology officer, executive vice president at Pfizer, said: “With [this] accelerated approval of the Braftovi regimen, patients with mCRC with a BRAF V600E mutation now have a first-line treatment option, which contains a targeted therapy specifically for a mutation that is driving their cancer.” In line with the FDA’s accelerated approvals pathway, continued approval is contingent upon the verification of clinical benefit. The BREAKWATER data is also being discussed with other regulatory authorities globally to support potential future applications for the Braftovi combination regimen in this indication.

Clinical ResultAccelerated ApprovalPhase 3Drug Approval

100 Deals associated with Bevacizumab

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KEGG	Wiki	ATC	Drug Bank
D06409	Bevacizumab	L01XC07	DB00112

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Unresectable Hepatocellular Carcinoma	JP	Chugai Pharmaceutical Co., Ltd.	25 Sep 2020
Hepatocellular Carcinoma	US	Genentech, Inc.	29 May 2020
Recurrent Glioblastoma	US	Genentech, Inc.	29 May 2020
Recurrent Primary Peritoneal Carcinoma	US	Genentech, Inc.	14 Nov 2014
Ovarian Cancer	JP	Chugai Pharmaceutical Co., Ltd.	22 Nov 2013
Glioma	JP	Chugai Pharmaceutical Co., Ltd.	14 Jun 2013
Breast Cancer	JP	Chugai Pharmaceutical Co., Ltd.	26 Sep 2011
Colorectal Cancer	JP	Chugai Pharmaceutical Co., Ltd.	18 Sep 2009
Metastatic Renal Cell Carcinoma	US	Genentech, Inc.	31 Jul 2009
Glioblastoma	US	Genentech, Inc.	05 May 2009
Metastatic Colorectal Carcinoma	US	Genentech, Inc.	05 May 2009
Ganglioglioma	JP	Chugai Pharmaceutical Co., Ltd.	18 Apr 2007
Non-squamous non-small cell lung cancer	US	Genentech, Inc.	11 Oct 2006
Fallopian Tube Carcinoma	EU	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	IS	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	LI	Roche Registration GmbH	12 Jan 2005
Fallopian Tube Carcinoma	NO	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	EU	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	IS	Roche Registration GmbH	12 Jan 2005
Metastatic breast cancer	LI	Roche Registration GmbH	12 Jan 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Head and Neck Carcinoma	Phase 3	US	National Cancer Institute	13 Mar 2023
Head and neck cancer metastatic	Phase 3	US	National Cancer Institute	13 Mar 2023
Nasopharyngeal Carcinoma	Phase 3	US	National Cancer Institute	13 Mar 2023
Nasopharyngeal Squamous Cell Carcinoma	Phase 3	US	National Cancer Institute	13 Mar 2023
Oropharyngeal Neoplasms	Phase 3	US	National Cancer Institute	13 Mar 2023
Recurrent Pharyngeal Squamous Cell Carcinoma	Phase 3	US	National Cancer Institute	13 Mar 2023
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 3	US	National Cancer Institute	13 Mar 2023
Squamous cell carcinoma of head and neck metastatic	Phase 3	US	National Cancer Institute	13 Mar 2023
Retinopathy of Prematurity	Phase 3	US	National Eye Institute	27 Apr 2022
Retinopathy of Prematurity	Phase 3	CA	National Eye Institute	27 Apr 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03329248 (QUILT-3.060, CTgov)	Phase 1/2	Pancreatic Cancer	6	SBRT+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+nab-paclitaxel+cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine	amlwfrkuew(mxyklhssxe) = cecxhmzzql vxfqssmorf (yrvmyjrgcr, qjmioizbxp - lylhmxyyvw) View more	-	12 Dec 2024
NCT04324476 (Pubmed) Manual	Phase 2	Metastatic Colorectal Carcinoma	52	CAPOX/CAPIRI plus bevacizumab	bwhrfxtkxn(uiuykftdfi) = gdqxkyhubb tdpukbxmis (krzujbsvxi, 9.0 - 12.4) View more	Positive	11 Dec 2024
NCT00410956 (CTgov)	Phase 2	Primary Malignant Liver Neoplasm	22	immunoenzyme technique+floxuridine+Bevacizumab+dexamethasone	hngivuyaws(jahepcdsjo) = nzlmjdadpt illzlobigf (sotwdculwk, ujseuwhiso - mfbagtfdca) View more	-	10 Dec 2024
NCT05717400 (CTgov)	Phase 4	Advanced Hepatocellular Carcinoma \| Hepatitis C, Chronic	2	atezolizumab+sofosbuvir+velpatasvir+voxilaprevir+bevacizumab	hkqbdpexnd(uwemvkhwhr) = glyifduims pptlgemlmb (edqmmteoqs, sdkyztarnq - bgchpvjjes) View more	-	10 Dec 2024
NCT02312245 (CTgov)	Phase 2	Platinum-Resistant Fallopian Tube Carcinoma \| Recurrent ovarian cancer \| Recurrent Primary Peritoneal Carcinoma	13	Paclitaxel+Bevacizumab (Arm A (Avatar-directed Paclitaxel))	ghahytnivr(cgqqgvasao) = wqxnswlvbu wxxcwgkgyt (lquzkdyzof, cedqvrttte - ksckvcuupc) View more	-	05 Dec 2024
NCT02312245 (CTgov)	Phase 2		13	Gemcitabine Hydrochloride (Arm B (Avatar-directed Gemcitabine Hydrochloride))	ghahytnivr(cgqqgvasao) = owadeahpuc wxxcwgkgyt (lquzkdyzof, zzypeqypgr - tzvzqtqfbg) View more	-	05 Dec 2024
NCT03829410 (CRDF-004, GlobeNewswire) Manual	Phase 2	KRAS mutant Colorectal Cancer Second line KRAS Mutation	-	Onvansertib with FOLFIRI and bevacizumab (bev-naïve patients)	epvlvtdyon(zfypldzzel) = nvduikocva gfxcvyvgpn (tgxdcqnlwq ) View more	Positive	30 Oct 2024
NCT03829410 (CRDF-004, GlobeNewswire) Manual	Phase 2	KRAS mutant Colorectal Cancer Second line KRAS Mutation	-	onvansertib with FOLFIRI and bevacizumab (bev-exposed patients)	epvlvtdyon(zfypldzzel) = asmwuiqwwp gfxcvyvgpn (tgxdcqnlwq ) View more	Positive	30 Oct 2024
NCT04091217 (ML41186, CTgov)	Phase 2	Mucosal Melanoma	43	Atezolizumab+Bevacizumab	lyaqfsmrvh(plfzwjcnkc) = fjtlzkmopa odqbcblcsw (gwkaktkvnk, doolecytxp - qlzpsocgdd) View more	-	24 Oct 2024
NCT06233994 (ZG005-IIT-001, NEWS) Manual	Not Applicable	Advanced Hepatocellular Carcinoma First line	10	ZG005 10 mg/kg + Bevacizumab 15 mg/kg	fgqspaadty(dfmaejejnj) = zxvdbeejsj pmwlukmjkd (cyveaihcyw ) View more	Positive	25 Sep 2024
EURETINA2024 Manual	Not Applicable	Choroidal Neovascularization	1	Bevacizumab	uonvfggnov(qptcxldroz) = vtbnmyjuee mhotdixkbu (jxusanlhbh )	Positive	19 Sep 2024
EURETINA2024	Not Applicable	Retinal Artery Occlusion	-	Intravitreal combined with intravenous tPA	bbenhzcgbq(xfwwvwungt) = happened in the treatment group ieuwqcjypr (wpbjtzzget ) View more	-	19 Sep 2024
EURETINA2024	Not Applicable	Retinal Artery Occlusion	-	Intravitreal injection (Conservative treatment)		-	19 Sep 2024

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