Cotellic

(Cobimetinib)

ApprovedSmall molecule

Cobimetinib is used to treat certain types of skin cancer (melanoma) that have a specific genetic mutation. It works by slowing or stopping the growth of cancer cells.[2] Cotellic is currently approved and in use across 30 indications[4].[1]

Cotellic is one of 676 small molecule programs targeting Cerebral arteriovenous malformation. It is currently in Approved.

Indications

Total Trials

Active Trials

675

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cerebral Arteriovenous MalformationApproved

Tic DisorderActive, not recruiting

Esophageal CancerActive, not recruiting

Cutaneous MelanomaApproved

Gallbladder CancerActive, not recruiting

Metastatic MelanomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Pancreatic Ductal AdenocarcinomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Colorectal AdenocarcinomaActive, not recruiting

Cerebral Arteriovenous MalformationApproved

Approved

Tic DisorderPhase 2

Active, not recruiting

Esophageal CancerPhase 1/Phase 2

Active, not recruiting

Cutaneous MelanomaApproved

Approved

Gallbladder CancerPhase 2

Active, not recruiting

Metastatic MelanomaPhase 3

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Pancreatic Ductal AdenocarcinomaPhase 1/Phase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Colorectal AdenocarcinomaPhase 3

Active, not recruiting

Showing 10 of 30 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Cotellic

Roche

Approved

3 2

Megace

Bristol-Myers Squibb

Preclinical

4 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

MS Contin

Merck & Co.

Preclinical

2 5

Zolymbus

AbbVie

Preclinical

1 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Chirocaine

PPurdue Pharma LP

Preclinical

1 8

Chantix

PPrism Pharmaceuticals

Preclinical

1 9

Vfend

PPrism Pharmaceuticals

Systemic Therapy

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Newly Diagnosed

NCT04409639

Q4 2026

Phase 1Active, not recruiting

Pancreatic Cancer

NCT05034627

Phase 3Active, not recruiting

Cholangiocarcinoma

NCT04551521

Phase 2Active, not recruiting

Non-Small Cell Lung Cancer

NCT03600701

Phase 2/3Active, not recruiting

Non-Small Cell Lung Cancer

NCT03178552

Phase 1Active, not recruiting

Melanoma

NCT02721459

Clinical

Trials by Indication[1]

Melanoma21 trials

A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Terminated· Roche logo

Roche·Phase 3·NCT03273153·446 enrolled

A Study of Adult Participants With BRAF V600 Mutation-Positive Advanced Melanoma Treated With Cobimetinib (Cotellic®) During the French Early Access Program (Temporary Authorization for Use [TAU])

Completed· Roche logo

Roche··NCT03139513·200 enrolled

Phase II Study of Cobimetinib in Combination With Vemurafenib in Active Melanoma Brain Metastases

Terminated·UUnknown Sponsor·Phase 2·NCT02230306·5 enrolled

Show 18 more trials

Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation

Completed·UUnknown Sponsor·Phase 1/2·NCT01959633·11 enrolled

Vemurafenib, Cobimetinib, Atezolizumab, and Tiragolumab in Treating Patients With High-Risk Stage III Melanoma

Active, not recruiting·MMayo Clinic·Phase 2·NCT03554083·59 enrolled

Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC

Terminated·UUniversity Hospital Tuebingen·Phase 2·NCT02303951·47 enrolled

Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 3·NCT02427893

Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma

Terminated·YYana Najjar·Phase 1·NCT02818023·9 enrolled

Study of Neo-adjuvant Use of Vemurafenib Plus Cobimetinib for BRAF Mutant Melanoma With Palpable Lymph Node Metastases

Unknown status·SSunnybrook Health Sciences Centre·Phase 2·NCT02036086·24 enrolled

Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma

Active, not recruiting·UUnknown Sponsor·Phase 2·NCT04722575·95 enrolled

A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases

Completed· Roche logo

Roche·Phase 2·NCT03625141·80 enrolled

Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy and Atezolizumab Monotherapy in Participants With Previously Untreated Advanced Melanoma

Completed· Roche logo

Roche·Phase 1·NCT03178851·155 enrolled

XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT02721459·26 enrolled

The Effects of Vemurafenib + Cobimetinib on Immunity in Patients With Melanoma

Terminated·GGeorgetown University·Phase 2·NCT01813214·5 enrolled

A Study to Detect V-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) V600 Mutation on Cell-Free Deoxyribonucleic Acid (cfDNA) From Plasma in Participants With Advanced Melanoma

Completed· Roche logo

Roche·Phase 2·NCT02768207·40 enrolled

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

Completed· Roche logo

Roche·Phase 3·NCT02908672·514 enrolled

Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases

Terminated·TTechnische Universität Dresden·Phase 2·NCT03430947·20 enrolled

Trial of Vemurafenib/Cobimetinib With or Without Bevacizumab in Patients With Stage IV BRAFV600 Mutant Melanoma

Terminated·MMelanoma Research Foundation Breakthrough Consortium·Phase 2·NCT01495988·10 enrolled

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma

Completed·—·Phase 1/2·NCT03101254·5 enrolled

Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

Completed·UUniversity Hospital, Essen·Phase 2·NCT02902029·186 enrolled

A Phase Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Nivolumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy

Active, not recruiting· Roche logo

Roche·Phase 1·NCT04835805·65 enrolled

Metastatic Melanoma6 trials

A Phase 1b Study of Atezolizumab in Combination With Vemurafenib or Vemurafenib Plus Cobimetinib in Participants With BRAFV600-Mutation Positive Metastatic Melanoma

Completed· Roche logo

Roche·Phase 1·NCT01656642·67 enrolled

Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients

Terminated·UUnknown Sponsor·Phase 2·NCT03224208·9 enrolled

A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

Completed· Roche logo

Roche·Phase 3·NCT01689519·495 enrolled

Show 3 more trials

IN10018 Monotherapy and Combination Therapy for Metastatic Melanoma

Completed·IInxMed (Shanghai) Co., Ltd.·Phase 1·NCT04109456·51 enrolled

A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma

Completed· Roche logo

Roche·Phase 1·NCT01271803·131 enrolled

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Completed· Pfizer logo

Pfizer··NCT05260684·716 enrolled

Locally Advanced or Metastatic Solid Tumors4 trials

A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT01562275·67 enrolled

Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT01988896·153 enrolled

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT02457793·24 enrolled

Show 1 more trial

Safety, Tolerability and Pharmacokinetics of Cobimetinib in Combination With Pictilisib in Patients With Locally Advanced or Metastatic Solid Tumors

Terminated· Roche logo

Roche·Phase 1·NCT00996892·178 enrolled

Non-Small Cell Lung Cancer4 trials

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03337698·314 enrolled

Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03600701·51 enrolled

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

Active, not recruiting· Roche logo

Roche·Phase 2/3·NCT03178552·1,000 enrolled

Show 1 more trial

NAUTIKA1: A Multicenter, Phase II, Neoadjuvant and Adjuvant Study of Multiple Therapies in Biomarker-selected Patients With Resectable Stages IB-III Non-small Cell Lung Cancer

Recruiting· Roche logo

Roche·Phase 2·NCT04302025·99 enrolled

Cancer3 trials

Safety, Tolerability, and Pharmacokinetics of Onartuzumab Combined With Vemurafenib and/or Cobimetinib in Cancer Patients

Withdrawn· Roche logo

Roche·Phase 1·NCT01974258

A MolEcularly Guided Anti-Cancer Drug Off-Label Trial

Active, not recruiting·UUppsala University Hospital·Phase 2·NCT04185831·167 enrolled

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

48 more indications

Breast Cancer3 trials

Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1/2·NCT03566485·12 enrolled

Pre-operative Immunotherapy Combination Strategies in Breast Cancer

Completed·QQueen Mary University of London·Phase 2·NCT03395899·71 enrolled

Atezolizumab, Cobimetinib, and Eribulin in Treating Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03202316·37 enrolled

ART2 trials

A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT01277718·20 enrolled

A Study of Relative Bioavailability and Food Effect Study of Cobimetinib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT01249131·20 enrolled

Acute Myeloid Leukemia2 trials

A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Completed· Roche logo

Roche·Phase 1·NCT02670044·88 enrolled

Enasidenib in Combination With Cobimetinib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Active, not recruiting·—·Phase 1·NCT05441514·3 enrolled

Efficacy and Safety2 trials

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Active, not recruiting· Roche logo

Roche·Phase 2·NCT04931342·176 enrolled

A Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab in Participants With Solid Tumors

Completed· Roche logo

Roche·Phase 2·NCT03264066·87 enrolled

Treatment2 trials

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.

Recruiting·CCancer Research UK·Phase 2/3·NCT05768178·30 enrolled

Solid Tumors2 trials

Study of Cobimetinib in Participants With Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT00467779·119 enrolled

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

Completed· Roche logo

Roche·Phase 1/2·NCT02639546·56 enrolled

BRAF2 trials

Cobimetinib for BRAF-wild-type or Mutated Histiocytoses

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04007848·54 enrolled

Phase II Study of BEvacizumab (Avastin) in Combination With Atezolizumab or Atezolizumab (Tencentriq) and Cobimetinib (Cotellic) in Patients With Untreated Melanoma Brain Metastases (TACo-BEAT-MBM)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03175432·29 enrolled

Pancreatic Cancer2 trials

Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT05034627·15 enrolled

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04005690·90 enrolled

Combination Therapy1 trial

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02060188·385 enrolled

Esophageal Cancer1 trial

A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03281369·214 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Advanced Solid Tumors1 trial

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 2·NCT02091141·673 enrolled

Gastrointestinal1 trial

Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors

Completed· Roche logo

Roche·Phase 1·NCT02876224·51 enrolled

Colorectal Cancer1 trial

Atezolizumab Monotherapy vs Atezolizumab Plus Cobimetinib in Liver Metastases From Colorectal Cancer

Withdrawn·NNiharika Mettu·Phase 2·NCT03340558

Biliary Tract Cancer1 trial

Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04941287·57 enrolled

Metastatic Cancer1 trial

A Study of MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS

Completed· Roche logo

Roche·Phase 1·NCT01986166·23 enrolled

Advanced or Metastatic Solid Tumors1 trial

A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT01928394·1,163 enrolled

Venous malformation1 trial

Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study)

Completed·UUniversity of Arkansas·Phase 2·NCT05125471·3 enrolled

Tic Disorder1 trial

Single-agent Cobimetinib for Adults With Histiocytic Disorders

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02649972·35 enrolled

Rare Tumor1 trial

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03108131·49 enrolled

Differentiated Thyroid Carcinoma1 trial

Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation

Recruiting·—·Phase 2·NCT06440850·21 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Study of Multiple Immunotherapy-Based Treatment Combinations in Participants With Metastatic Pancreatic Ductal Adenocarcinoma (Morpheus-Pancreatic Cancer)

Completed· Roche logo

Roche·Phase 1/2·NCT03193190·341 enrolled

Metastatic Colorectal Cancer1 trial

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Completed· Roche logo

Roche·Phase 2·NCT02291289·1,044 enrolled

Gallbladder Cancer1 trial

Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03201458·86 enrolled

Triple-Negative Breast Cancer1 trial

A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread

Terminated· Roche logo

Roche·Phase 2·NCT02322814·169 enrolled

Cancer of Unknown Primary Site1 trial

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Craniopharyngioma1 trial

Vemurafenib and Cobimetinib in Treating Patients With BRAF V600E Mutation Positive Craniopharyngioma

Active, not recruiting·AAlliance for Clinical Trials in Oncology·Phase 2·NCT03224767·24 enrolled

Randomized1 trial

A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation

Completed· Roche logo

Roche·Phase 1·NCT02136524·28 enrolled

Thyroid Cancer1 trial

Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03181100·50 enrolled

Tics1 trial

A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants

Completed· Roche logo

Roche·Phase 1·NCT01929876·16 enrolled

Endometrial Cancer1 trial

Testing the Combination of APG-1252 (Pelcitoclax) and Cobimetinib in Recurrent Ovarian and Endometrial Cancers

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05691504·42 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Refractory Solid Tumors1 trial

Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC

Completed· Revolution Medicines logo

Revolution Medicines·Phase 1/2·NCT03989115·113 enrolled

Newly Diagnosed1 trial

Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations

Active, not recruiting·UUniversity of Utah·Phase 2·NCT04409639·29 enrolled

Recurrent1 trial

BEACON - ABC in Recurrent Platinum Resistant HGSOC

Unknown status·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT03363867·30 enrolled

Patients With Advanced Solid Tumors1 trial

Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors

Terminated·AABM Therapeutics Corporation·Phase 1·NCT04190628·53 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

Ovarian Cancer1 trial

A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer

Completed· Roche logo

Roche·Phase 1·NCT03695380·77 enrolled

Immune Checkpoint Blockade1 trial

Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies

Terminated·—·Phase 1/2·NCT04214418·27 enrolled

Liver1 trial

A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage

Completed· Roche logo

Roche·Phase 1·NCT02300025·28 enrolled

Soft Tissue Sarcoma1 trial

MEK Inhibitor and a PDL1 Inhibitor Patients With Locally Advanced and/or Metastatic Soft Tissue Sarcoma

Active, not recruiting·CCentre Leon Berard·Phase 1/2·NCT04216953·320 enrolled

Advanced1 trial

A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC

Active, not recruiting·MMassachusetts General Hospital·Phase 1/2·NCT03202940·16 enrolled

Langerhans Cell Histiocytosis1 trial

Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders

Recruiting·CCarl Allen·Phase 2·NCT04079179·90 enrolled

Multiple Myeloma1 trial

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma

Completed· Roche logo

Roche·Phase 1/2·NCT03312530·49 enrolled

Colorectal Adenocarcinoma1 trial

A Study to Investigate Efficacy and Safety of Cobimetinib Plus Atezolizumab and Atezolizumab Monotherapy Versus Regorafenib in Participants With Metastatic Colorectal Adenocarcinoma (COTEZO IMblaze370)

Completed· Roche logo

Roche·Phase 3·NCT02788279·363 enrolled

Pancreatic Ductal Carcinoma1 trial

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06813079·25 enrolled

Cholangiocarcinoma1 trial

FIGHT-302: Pemigatinib vs Chemo in FGFR2+ CCA

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT04551521·432 enrolled

Unspecified1 trial

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Active, not recruiting· Roche logo

Roche·Phase 3·NCT03768063·1,000 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 10, 2015

COTELLIC

NDA NDA206192

Sources

References

[1]
ClinicalTrials.gov — 95 trial records for Cobimetinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cotellic drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cobimetinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cobimetinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206192). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cotellic. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dual Specificity Mitogen-Activated Protein Kinase Kinase 1 Inhibitor; Dual Specificity Mitogen-Activated Protein Kinase Kinase 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

Oct 5, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11597699Oct 5, 2026

8362002Oct 5, 2026

8362002*PEDApr 5, 2027

7803839Nov 10, 2029

7803839*PEDMay 10, 2030

8 more patents

11087354Jun 22, 2034

11087354*PEDDec 22, 2034

10478400Jun 29, 2036

11254649Jun 30, 2036

10590102Jun 30, 2036

10478400*PEDDec 29, 2036

11254649*PEDDec 30, 2036

10590102*PEDDec 30, 2036

Cotellic

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Melanoma21 trials

Metastatic Melanoma6 trials

Locally Advanced or Metastatic Solid Tumors4 trials

Non-Small Cell Lung Cancer4 trials

Cancer3 trials

Breast Cancer3 trials

ART2 trials

Acute Myeloid Leukemia2 trials

Efficacy and Safety2 trials

Treatment2 trials

Solid Tumors2 trials

BRAF2 trials

Pancreatic Cancer2 trials

Combination Therapy1 trial

Esophageal Cancer1 trial

Immunotherapy1 trial

Advanced Solid Tumors1 trial

Gastrointestinal1 trial

Colorectal Cancer1 trial

Biliary Tract Cancer1 trial

Metastatic Cancer1 trial

Advanced or Metastatic Solid Tumors1 trial

Venous malformation1 trial

Tic Disorder1 trial

Rare Tumor1 trial

Differentiated Thyroid Carcinoma1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Metastatic Colorectal Cancer1 trial

Gallbladder Cancer1 trial

Triple-Negative Breast Cancer1 trial

Cancer of Unknown Primary Site1 trial

Craniopharyngioma1 trial

Randomized1 trial

Thyroid Cancer1 trial

Tics1 trial

Endometrial Cancer1 trial

Pilot Study1 trial

Refractory Solid Tumors1 trial

Newly Diagnosed1 trial

Recurrent1 trial

Patients With Advanced Solid Tumors1 trial

Trial1 trial

Ovarian Cancer1 trial

Immune Checkpoint Blockade1 trial

Liver1 trial

Soft Tissue Sarcoma1 trial

Advanced1 trial

Langerhans Cell Histiocytosis1 trial

Multiple Myeloma1 trial

Colorectal Adenocarcinoma1 trial

Pancreatic Ductal Carcinoma1 trial

Cholangiocarcinoma1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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