The aim of this study is to evaluate the activity, in terms of best response according to RECIST criteria 1.1 as assessed by the local investigator, of the ctDNA-guided retreatment with encorafenib plus cetuximab in BRAFV600E mutated mCRC patients experiencing benefit from previous exposure to encorafenib plus cetuximab (+/- chemotherapy) and with BRAFV600E mutated, KRAS, NRAS and MAP2K1 wild-type and MET not amplified status on ctDNA at the time of study entry.

Start Date23 Jul 2024

Sponsor / Collaborator

Gruppo Oncologico del Nord-Ovest

[+2]

NCT05615818 / RecruitingPhase 3IIT

Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial

The object of this trial is to evaluate whether the introduction of a targeted therapy after 4 cycles of the current standard-of-care treatment for advanced biliary cancer is superior to continuing with the standard treatment.
The trial is composed of two phases: (i) An initial screening phase to identify a suitable patient population, during which a molecular profile of the patient's tumour will be obtained, and (ii) a randomised comparative trial in which patients with disease control after 4 cycles of standard treatment, and whose tumour harbours a targetable molecular alteration, will be randomised (2:1) to receive either a matched targeted therapy or to continue with the standard treatment.

Start Date18 Jul 2024

Sponsor / Collaborator

UNICANCER

[+8]

100 Clinical Results associated with Encorafenib

100 Translational Medicine associated with Encorafenib

100 Patents (Medical) associated with Encorafenib

352

Literatures (Medical) associated with Encorafenib

01 Feb 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Review

Author: Fassan, Matteo ; Pastorino, Alessandro ; Pagni, Fabio ; Grillo, Federica ; Latiano, Tiziana Pia ; Intini, Rossana ; Malapelle, Umberto ; Parente, Paola ; Martinelli, Erika ; Rocco, Elena Guerini ; Pietrantonio, Filippo ; Bergamo, Francesca ; Cremolini, Chiara ; Angerilli, Valentina ; Guerini Rocco, Elena ; Salvatore, Lisa ; Lonardi, Sara ; Normanno, Nicola

BRAF p.V600E exon 15 hotspot mutation can identify a molecular subgroup of metastatic colorectal cancer (mCRC) patients exhibiting poor prognosis under the conventional chemotherapy regimen. Recently, the chemotherapy-free combination of encorafenib and cetuximab has been approved as the standard of care for previously treated BRAF p.V600E mCRC patients, and genomic testing for BRAF mutations at the time of mCRC diagnosis is currently recommended. In clinical practice, BRAF mutation testing strategies are dramatically impacted by a lack of harmonization and standardization, both in the pre-analytical and analytical phases, which can result in BRAF-mutated patients not receiving the most appropriate therapy at recurrence. This paper proposes nine statements providing practical and concise advice on BRAF mutation testing in CRC, derived from collegial discussion and analysis of a multidisciplinary team of experts, including referral Italian oncologists and pathologists. The statements overview pivotal aspects implied in the detection, treatment and management of BRAF-mutated patients and have been drafted to represent a valuable tool for healthcare professionals committed to mCRC patient management. In addition, they represent a platform for implementing diagnostic-therapeutic workflows that can adapt to the variability of local resources while respecting the high-quality standards required by modern precision oncology.

31 Dec 2024·CNS oncology

BRAF V600E-mutant colorectal cancer with CNS metastases treated successfully with encorafenib, binimetinib and cetuximab

Article

Author: Kato, Ken ; Takashima, Atsuo ; Hirose, Toshiharu ; Hirano, Hidekazu ; Imai, Toru ; Shoji, Hirokazu ; Awatsu, Takahito ; Matsuguma, Kunihito ; Okita, Natsuko

This report describes a case of BRAF V600E-mutated colorectal cancer with CNS metastases in which treatment with encorafenib, binimetinib and cetuximab was effective. There is limited information on the ability of encorafenib, binimetinib and cetuximab to enter the CNS.The patient was a 53-year-old man was diagnosed with ascending colon cancer (cT3N3M1c stage IVc). BRAF V600E mutation was confirmed. FOLFOX was started, but CNS metastases soon appeared. Encorafenib, binimetinib and cetuximab were administered and had a favorable effect on the CNS lesions. The patient initially responded well, but his disease progressed 2 months later. Further research is needed to improve management strategies for BRAF V600E-mutated colorectal cancer with CNS metastases.

16 Dec 2024·JOURNAL OF CLINICAL INVESTIGATION

Article

Author: Wang, Huogang ; Chen, Jiaxin ; Wang, Huijuan ; Ju, Zhenyu ; Liu, Yingqiang ; Liu, Yinqiang ; Chan, David W. ; Wang, Jiawei ; Meng, Qing ; Song, Zhangfa ; Zhou, Wei ; Luo, Xin ; Chan, David W ; Chen, Xiaoyu

BRAFV600E-mutant metastatic colorectal cancer (mCRC) is associated with poor prognosis. The combination of anti-BRAF/anti-EGFR (encorafenib/cetuximab) treatment for patients with BRAFV600E-mutant mCRC improves clinical benefits; unfortunately, inevitable acquired resistance limits the treatment outcome, and the mechanism has not been validated. Here, we discovered that monoacylglycerol O-acyltransferase 3-mediated (MOGAT3-mediated) diacylglycerol (DAG) accumulation contributed to acquired resistance to encorafenib/cetuximab by dissecting a BRAFV600E-mutant mCRC patient-derived xenograft (PDX) model exposed to encorafenib/cetuximab administration. Mechanistically, the upregulated MOGAT3 promoted DAG synthesis and reduced fatty acid oxidation-promoting DAG accumulation and activated PKCα/CRAF/MEK/ERK signaling, driving acquired resistance. Resistance-induced hypoxia promoted MOGAT3 transcriptional elevation; simultaneously, MOGAT3-mediated DAG accumulation increased HIF1A expression at the translation level through PKCα/CRAF/eIF4E activation, strengthening the resistance status. Intriguingly, reducing intratumoral DAG with fenofibrate or PF-06471553 restored the antitumor efficacy of encorafenib/cetuximab in resistant BRAFV600E-mutant mCRC, which interrupted PKCα/CRAF/MEK/ERK signaling. These findings reveal the critical role of the metabolite DAG as a modulator of encorafenib/cetuximab efficacy in BRAFV600E-mutant mCRC, suggesting that fenofibrate might prove beneficial for resistant BRAFV600E-mutant mCRC patients.

106

News (Medical) associated with Encorafenib

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

23 Dec 2024

·www.pharmaceutical-technology.com

Pfizer’s colorectal cancer combo therapy gains accelerated approval from FDA

Pfizer holds exclusive rights to BRAFTOVI in the Middle East, Canada, Latin America, Africa, and the US. Credit: ShU studio/Shutterstock. Pfizer has gained accelerated approval from the US Food and Drug Administration (FDA) for BRAFTOVI (encorafenib) in conjunction with cetuximab and mFOLFOX6 for treating metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, confirmed by an FDA-approved test. This decision follows a significant improvement in response rate and durability response observed in the treatment-naïve subjects in the randomised, open-label, multicentre Phase III BREAKWATER trial that demonstrated an overall response rate of 61% with the BRAFTOVI regimen compared to 40% in the control arm. The ongoing active-controlled trial assesses the combination with or without mFOLFOX6 chemotherapy in previously untreated mCRC subjects with the BRAF V600E mutation. FDA has granted this accelerated approval with the condition that further clinical benefits be verified for continued approval. This accelerated approval is part of the FDA’s Project FrontRunner, aimed at advancing cancer drug development. Pfizer executive vice-president and chief oncology officer Chris Boshoff said: “For more than a decade, Pfizer has been a pioneer in delivering targeted therapies for molecular-driven cancers. With today’s accelerated approval of the BRAFTOVI regimen, patients with metastatic colorectal cancer 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. “This milestone adds to our legacy of developing innovative medicines in BRAF tumours, some of the hardest-to-treat cancers. We look forward to continuing to expand our portfolio, including the exploration of a next-generation brain-penetrant BRAF inhibitor.” Pfizer’s application for BRAFTOVI received priority review and utilised the Real-Time Oncology Review (RTOR) pilot programme. Reviews are currently ongoing in Brazil and Canada, with discussions with other regulatory authorities globally to support additional licensing applications for the BRAFTOVI combination regimen. In October 2023, the US regulator approved the combination of BRAFTOVI and Mektovi for treating metastatic non-small cell lung cancer (NSCLC). Pfizer holds exclusive rights to BRAFTOVI in Canada, Latin America, the Middle East, Africa, and the US while Ono Pharmaceutical , Medison, and Pierre Fabre have rights in other specific territories.

Phase 3Priority ReviewAccelerated ApprovalLicense out/inDrug Approval

21 Dec 2024

·pipelinereview.com

U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

NEW YORK, NY, USA I December 20, 2024 I Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. i The indication was approved based on a statistically significant and clinically meaningful improvement in response rate and durability of response in treatment-naïve patients treated with BRAFTOVI in combination with cetuximab and mFOLFOX6 from the Phase 3 BREAKWATER trial. Continued approval for this indication is contingent upon verification of clinical benefit. This accelerated approval is among the first in the industry to be conducted under the FDA’s Project FrontRunner, which seeks to support the development and approval of new cancer drugs for advanced or metastatic disease. “Historically, treatment options have been limited and outcomes poor for patients diagnosed with metastatic colorectal cancer with BRAF mutations,” said Scott Kopetz, M.D., Ph.D., FACP, Professor and Deputy Chair of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and co-principal investigator of the BREAKWATER trial. “As the first and only combination regimen featuring a BRAF-targeted therapy for this patient population, usable even in first-line treatment, the encorafenib regimen has demonstrated high response rates that are rapid and durable. This represents an encouraging sign of continued disease control and a source of renewed hope for patients.” The ongoing BREAKWATER trial is evaluating BRAFTOVI plus cetuximab with or without chemotherapy (mFOLFOX6) in previously untreated mCRC patients who harbor a BRAF V600E mutation. It is the only Phase 3 trial for a BRAF-targeted therapy regimen in first-line BRAF V600E -mutant mCRC. The trial met one of the dual primary endpoints of confirmed overall response rate (ORR), with a statistically significant improvement over standard of care: ORR 61% (95% confidence interval [CI]: 52, 70) for BRAFTOVI in combination with cetuximab and mFOLFOX6 compared with ORR 40% (95% CI: 31, 49) for chemotherapy, with or without bevacizumab (p=0.0008). 1 The median duration of response (DoR) was 13.9 months (95% CI: 8.5, not estimable) for the BRAFTOVI combination regimen versus 11.1 months (95% CI: 6.7, 12.7) for chemotherapy, with or without bevacizumab. 1 The Phase 3 BREAKWATER trial is ongoing, and results from the full dataset will be presented at upcoming medical meetings. “For more than a decade, Pfizer has been a pioneer in delivering targeted therapies for molecular-driven cancers. With today’s accelerated approval of the BRAFTOVI regimen, patients with metastatic colorectal cancer 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,” said Chris Boshoff, M.D., Ph.D., Chief Oncology Officer, Executive Vice President, Pfizer. “This milestone adds to our legacy of developing innovative medicines in BRAF tumors, some of the hardest-to-treat cancers. We look forward to continuing to expand our portfolio, including the exploration of a next-generation brain-penetrant BRAF inhibitor.” The safety profile of BRAFTOVI in combination with cetuximab and mFOLFOX6 in the BREAKWATER trial was consistent with the known safety profile of each respective agent. No new safety signals were identified. The most common adverse reactions (≥25%) were peripheral neuropathy, nausea, fatigue, rash, diarrhea, decreased appetite, vomiting, hemorrhage, abdominal pain, and pyrexia. 1 Among patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6, 12% experienced an adverse reaction that resulted in permanent discontinuation of BRAFTOVI; the most common adverse reactions (≥1%) included elevated lipase levels. “Finding out that your cancer has spread can be a frightening time for those with colorectal cancer and their loved ones. The prognosis for those receiving a metastatic colorectal cancer diagnosis has improved slightly in recent years, but the same cannot be said for those with a BRAF mutation who unfortunately face an especially aggressive disease and worse outcomes,” said Michael Sapienza, Chief Executive Officer of the Colorectal Cancer Alliance. “Today’s approval of the first combination regimen including a BRAF-targeted therapy for BRAF V600E -mutant metastatic colorectal cancer, which can be used for previously untreated patients, offers new promise for the community and marks an important step forward in our collective mission to end this disease.” This application was granted priority review, used the Real-Time Oncology Review (RTOR) pilot program, and was conducted under Project Orbis , with application reviews ongoing for Project Orbis partners, including Canada and Brazil. The BREAKWATER data are also being discussed with other regulatory authorities around the world to support potential future additional license applications for the BRAFTOVI combination regimen in this indication. This accelerated approval follows the previous FDA approval for BRAFTOVI in combination with cetuximab for adults with mCRC with a BRAF V600E mutation after prior therapy. About Colorectal Cancer (CRC) CRC is the third most common type of cancer in the world, with approximately 1.8 million new diagnoses in 2022. 2 Overall, the lifetime risk of developing CRC is about 1 in 23 for men and 1 in 25 for women. 3 In the U.S. alone, an estimated 152,810 people will be diagnosed with cancer of the colon or rectum in 2024, and approximately 53,000 are estimated to die from the disease each year. 4 For 20% of those diagnosed with CRC, the disease has metastasized, or spread, making it harder to treat. 5 BRAF mutations are estimated to occur in 8-10% of people with mCRC and represent a poor prognosis for these patients. 6 The BRAF V600E mutation is the most common BRAF mutation and the risk of mortality in CRC patients with the BRAF V600E mutation is more than double that of patients with no known mutation present. 6,7 Despite the high unmet need in BRAF V600E -mutant mCRC, prior to today there were no approved biomarker-driven therapies specifically indicated for people with previously untreated BRAF V600E -mutant mCRC. 8,9 About BREAKWATER BREAKWATER is a Phase 3, randomized, active-controlled, open-label, multicenter trial of BRAFTOVI with cetuximab, alone or in combination with chemotherapy, in participants with previously untreated BRAF V600E -mutant mCRC. In the Phase 3 portion of the study, patients were randomized to receive BRAFTOVI 300 mg orally once-daily in combination with cetuximab (discontinued after randomization of 158 patients), BRAFTOVI 300 mg orally once-daily in combination with cetuximab and mFOLFOX6 (n=236), or mFOLFOX6, FOLFOXIRI, or CAPOX each with or without bevacizumab (control arm) (n=243). The dual primary endpoints are ORR and progression-free survival (PFS), as assessed by blinded independent central review (BICR). Key secondary endpoints include DoR as assessed by BICR, time to response by BICR, overall survival, and safety. About BRAFTOVI ® (encorafenib) BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E . Inappropriate activation of proteins in the MAPK signaling pathway (RAS-RAF-MEK-ERK) has been shown to occur in certain cancers, including CRC. Pfizer has exclusive rights to BRAFTOVI in the U.S., Canada, Latin America, Middle East, and Africa. Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialize the product in Japan and South Korea, Medison has exclusive rights to commercialize the product in Israel and Pierre Fabre has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea). U.S. INDICATION AND USAGE BRAFTOVI ® (encorafenib) is indicated, in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with mCRC with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC. View the full Prescribing Information . There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly. About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer . References 1 BRAFTOVI (encorafenib) Prescribing Information. Array BioPharma, Inc.; December 2024 2 American Cancer Society. Global Cancer Facts & Figures 5th Edition. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/global-cancer-facts-and-figures/global-cancer-facts-and-figures-2024.pdf. Last accessed: December 2024. 3 American Cancer Society. Key Statistics for Colorectal Cancer. Available at: https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html. Last accessed: December 2024. 4 American Cancer Society. Cancer Facts & Figures 2024. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf. Last accessed: December 2024. 5 Ciardiello F, Ciardiello D, Martini G, et al . Clinical management of metastatic colorectal cancer in the era of precision medicine. CA Cancer J Clin . 2022;72:372–40. 6 Djanani A, Eller S, Öfner D, et al . The role of BRAF in metastatic colorectal carcinoma-past, present, and future. Int J Mol Sci . 2020;21(23):9001. 7 Safaee Ardekani G, Jafarnejad SM, Tan L, et al . The prognostic value of BRAF mutation in colorectal cancer and melanoma: a systematic review and meta-analysis. PloS ONE . 2012;7(10):e47054. 8 NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Colon Cancer. V.5.2024 © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed December 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. 9 Cervantes A, Adam R, Roselló S, et al . Metastatic colorectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol . 2023;34(1):10–32. SOURCE: Pfizer

Phase 3Clinical ResultDrug ApprovalPriority ReviewAccelerated Approval

100 Deals associated with Encorafenib

External Link

KEGG	Wiki	ATC	Drug Bank
D11053	Encorafenib	L01XE46	DB11718

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
BRAF mutated anaplastic thyroid cancer	JP	Ono Pharmaceutical Co., Ltd.	17 May 2024
Thyroid Cancer with BRAF mutation	JP	Ono Pharmaceutical Co., Ltd.	17 May 2024
BRAF V600E mutant Non-small Cell Lung Cancer	US	Array BioPharma, Inc.	11 Oct 2023
BRAF V600 mutant Colorectal Cancer	KR	Ono Pharma Korea Co., Ltd.	19 Aug 2021
Metastatic Colorectal Carcinoma	CA	Pfizer Canada ULC	31 Mar 2021
BRAF mutation positive Melanoma	JP	Ono Pharmaceutical Co., Ltd.	27 Nov 2020
BRAF Mutation colorectal cancers	JP	Ono Pharmaceutical Co., Ltd.	08 Jan 2019
BRAF V600E mutant Colorectal Cancer	EU	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600E mutant Colorectal Cancer	IS	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600E mutant Colorectal Cancer	LI	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600E mutant Colorectal Cancer	NO	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600 mutation-positive Melanoma	EU	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600 mutation-positive Melanoma	IS	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600 mutation-positive Melanoma	LI	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600 mutation-positive Melanoma	NO	Pierre Fabre Médicament SAS	19 Sep 2018
BRAF V600E Mutation-Positive Melanoma	US	Array BioPharma, Inc.	27 Jun 2018
BRAF V600K Mutation-Positive Melanoma	US	Array BioPharma, Inc.	27 Jun 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 3	AR	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	AU	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	AT	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	BE	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	BR	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	CA	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	CZ	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	FR	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	DE	Pierre Fabre Médicament SAS	02 May 2022
Melanoma	Phase 3	GR	Pierre Fabre Médicament SAS	02 May 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03843775 (CTgov)	Phase 1/2	BRAF mutation Solid Tumors	17	Encorafenib+Binimetinib (Dose Level 1)	qdywyxogvz(aoteobdejc) = yhzkanvimq ozhftbhfan (btarososyq, wgakvpvhlm - lwdhxlvucn) View more	-	21 Oct 2024
				Encorafenib+Binimetinib (Dose Level 2)	zsogdudpfh(guwaqgrvij) = zecpmetodj zixlqiupun (bwfwvhlted, uapyaspyqf - zmcfmowvpi) View more
NCT03864042 (CTgov)	Phase 1	Advanced Malignant Solid Neoplasm \| Metastatic melanoma \| Unresectable Melanoma ... View more	56	omeprazole+encorafenib+midazolam+caffeine+binimetinib+dextromethorphan+losartan (Arm 1 - CYP Probe Cocktail)	ahrrrxxmrz(lwnrmjrsoh) = rfgrtljyqu wxeuiyiwjg (pakoodnkbv, wkmekovcpg - fuajsyqvpl) View more	-	27 Sep 2024
				rosuvastatin+bupropion immediate release (IR)+encorafenib+binimetinib (Arm 2 - Rosuvastatin and Bupropion)	fwofrmfbhm(trffuyhiqs) = cjlvjyfpad cxfvcomhyk (zxemwxqlto, krohgjrrzv - hicrjgsyfg) View more
NCT04526782 (IFCT-1904 \| ENCO-BRAF, ESMO2024) Manual	Phase 2	BRAF V600E mutant Non-small Cell Lung Cancer First line BRAF V600E-mutant	64	encorafenib 450mgbinimetinib	zobnvtwzxu(hyeeplgclp) = hwpnuwpjjf ahejyvpxon (wniubfsacz, 55.0 - 78.3) View more	Positive	14 Sep 2024
NCT04607421 (BREAKWATER, ESMO2024) Manual	Phase 3	BRAF V600E mutant Colorectal Cancer Second line \| First line BRAF V600E	30	Encorafenib 30cetuximab	zrjzdnxxul(vilxveqkbc) = none jozkmcmiqs (fmgpajpvjb ) View more	Positive	14 Sep 2024
				Encorafenib00 cetuximab
NCT03915951 (PHAROS, WCLC2024) Manual	Phase 2	BRAF V600E mutant Non-small Cell Lung Cancer Second line \| First line BRAF V600E	98	Encorafenib 450 mBinimetiniby plus Binimetinib 45 mg twice daily	wtlyysjarn(rxuikwrqgz) = vxdcbotltj gutqojfwsg (vrattvyjmh ) View more	Positive	10 Sep 2024
				EncorafenibBinimetinib	wtlyysjarn(rxuikwrqgz) = salvmlyvlg gutqojfwsg (vrattvyjmh ) View more
ESMO_GI2024 Manual	Not Applicable	BRAF V600E mutant Colorectal Cancer BRAF V600E	489	Encorafenib+Binimetinib+Cetuximab	ojvgkuoxuf(dkrvcmrfng) = dxkxhvpldg johvmfvbts (iobmifynsa, 0.14 - 0.64) View more	Positive	27 Jun 2024
NCT05003622 (OCEANI, CTgov)	Phase 1	BRAF V600E Mutation-Positive Melanoma \| Metastatic Solid Tumor \| BRAF V600E mutant Non-small Cell Lung Cancer ... View more	3	Encorafenib	jmkntnfjbc(aixfehllup) = ximpqrvbxg ezmfmhktry (mjdwhxwjxb, iojkblexlc - hlxikxetip) View more	-	24 Jun 2024
NCT03235245 (EBIN, ASCO2024) Manual	Phase 2	BRAF V600K Mutation-Positive Melanoma \| BRAF V600E Mutation-Positive Melanoma BRAF V600K \| BRAF V600E	135	Nivolumab + Ipilimumab	tzwjyfifpc(ezpyyngkam): HR = 0.87 (90% CI, 0.67 - 1.12), P-Value = 0.36 View more	Negative	02 Jun 2024
				Encorafenib + Binimetinib +ipilimumab +nivolumab
NCT05004350 (NAUTICAL CRC, ASCO2024) Manual	Phase 2	BRAF V600E mutant Colorectal Cancer Second line \| Third line BRAF V600E mutation	97	Encorafenib + Cetuximab	hrdxzvbbjz(gxrwnkhufp) = hhrtoqxzrg nnmadztqcn (utgkjzepkf ) View more	Positive	02 Jun 2024
				Irinotecan + Cetuximab or FOLFIRI + Cetuximab	hrdxzvbbjz(gxrwnkhufp) = yqtrryusbf nnmadztqcn (utgkjzepkf ) View more
NCT04673955 (BERING-CRC, ASCO2024) Manual	Not Applicable	BRAF V600E mutant Colorectal Cancer BRAF V600E	95	Encorafenib plcetuximabmab	gwwpqtfmtm(wyicwusitz) = xdmsfnbkam fyoqvukgwv (pbnutnzliq ) View more	Positive	24 May 2024

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis