Hoffmann-La Roche clinical trial failures

Phase III Asthma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor decision to discontinue lebrikizumab development for the treatment of asthma.

Phase III Non-small Cell Lung Cancer (NSCLC) trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Decision to terminate study was driven by results from preceding tiragolumab study (SKYSCRAPER-06;NCT04619797) \& sponsor's strategic priorities, not due to safety risks or quality reasons for any of molecules/combinations investigated in this study.

Phase I Solid Tumors trial by Hoffmann-La Roche. Stop reason: SAFETY.

After risk/benefit analysis, there was a very low probability (4.4%) of meeting the prespecified gating criteria for the Objective Response Rate at the final analysis.

Phase I Carcinoma, Non-Small-Cell Lung trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Study was closed early as the sponsor decided not to continue development of certain treatment combinations.

Phase I Gastric and Gastroesophageal Junction Carcinoma trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Study was closed early as the sponsor decided not to continue development of certain treatment combinations.

Phase III Carcinoma, Renal Cell trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

As the study did not meet it's primary endpoint a decision was made to terminate the study.

Phase II Non-Small Cell Lung Cancer (NSCLC) trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Study was terminated as data became available from Phase 3 trials of perioperative regimens combining chemotherapy with immunotherapy showing improved efficacy outcomes versus chemotherapy alone.

Phase III RET-fusion Non Small Cell Lung Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Early termination of the study resulted from organizational and commercial decisions that led to the discontinuation of pralsetinib's global marketing and development in all territories (excluding US and Greater China).

Phase II Antiphospholipid Syndrome trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The study was discontinued due to a strategic business/portfolio decision by the sponsor and was not related to any medical or safety issue.

Phase II Colorectal Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision

Phase I Chronic Hepatitis B trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The Sponsor decided to discontinue the development of RO7565020 and as a result the BP44118 study was terminated.

Phase II Dup15q Syndrome trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The study was terminated due to sponsor decision and not related to safety or tolerability.

Phase II Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Study terminated by sponsor.

Phase III Metastatic Breast Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Due to low enrollment, the Sponsor decided to prematurely terminate the study

Phase I Non-muscle Invasive Bladder Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision of the Sponsor.

Phase III Alzheimers Disease trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision to terminate development of gantenerumab for treatment of people at risk for or at earliest stages of Alzheimer disease (AD) following results of a pre-planned analysis of safety \& efficacy of gantenerumab in Graduate I\&II (WN29922/WN39658).

Phase I Solid Tumors trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The sponsor decided to terminate the study early, due to recruitment challenges for Part II and, based on the totality of data generated with a low likelihood of achieving the targeted efficacy, to open Part III.

Phase III Carcinoma, Hepatocellular trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was completed as pre-specified in the protocol. Study was terminated only for participants who were in the study even after 24 months of follow-up as specified in the protocol.

Phase III Generalized Myasthenia Gravis trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Sponsor decided to halt development of satralizumab in generalized myasthenia gravis and discontinued further dosing with the study drug (while the OLE period was ongoing) upon reviewing the primary results (DB period).

Phase IV Neuromyelitis Optica Spectrum Disorder trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Study has proved infeasible to recruit in sufficient numbers. There are insufficient eligible patients presenting to sites.

Phase III Multiple Sclerosis, Relapsing-Remitting trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was terminated earlier as the study sponsor collected sufficient data to perform all analyses as per pre-specified endpoints in the study protocol.

Phase I Ulcerative Colitis trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was terminated due to program discontinuation, based on mixed efficacy results in the adult ulcerative colitis and Crohn's disease studies. There were no safety concerns.

Phase II Solid Tumors trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Global desprioritization decision by the sponsor.

Phase I Acute Myeloid Leukemia (AML) trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Study was terminated by the sponsor based on insufficient tolerability and efficacy to proceed beyond Part 1b.

Phase III Crohn Disease trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.

Phase II Stomach Neoplasms trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision to terminate the study after Stage 1; will not proceed with Stage 2.

Phase I Breast Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The decision to not open the Phase III portion was based on a strategic sponsor decision and not driven by any safety concerns.

Phase III Ulcerative Colitis trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was terminated due to program discontinuation, based on mixed efficacy results in the parent studies. There were no safety concerns.

Phase III Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

Decision to terminate the study as its primary endpoint of investigator-assessed event free survival (INV-EFS) was not met at its final EFS analysis. No new safety signals were identified.

Phase I Non-Hodgkin Lymphoma, Follicular Lymphoma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Study was terminated due to Sponsor decision.

Phase I Lymphoma, Non-Hodgkin trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The study was terminated due to sponsor portfolio re-alignment.

Phase III Triple Negative Breast Cancer trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

The study was terminated by the sponsor following interim analysis as the primary endpoint of iDFS crossed the pre-specified futility boundary of hazard ratio \> 1 in the Intent-to-Treat (ITT) population.

Phase II Schizophrenia, Schizoaffective Disorder trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

This study was discontinued due to an interim analysis which indicated that ralmitaront was unlikely to meet its primary endpoint.

Phase I Colorectal Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The Sponsor terminated the study because development of cibisatamab has been discontinued.

Phase I Lymphoma, Large B-Cell, Diffuse trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the BO42203 study.

Phase I Renal Cell Carcinoma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor decision (not related to safety, efficacy or quality).

Phase III Idiopathic Pulmonary Fibrosis trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.

Phase III Alzheimer Disease trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).

Phase III Idiopathic Pulmonary Fibrosis trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.

Phase II Alzheimer Disease trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).

Phase I Solid Tumors trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Halted in order to focus on the ongoing combination of RO7296682 with Atezolizumab, evaluated in study BP42595, as a higher likelihood for efficacy is expected in combination with Atezolizumab as compared to the monotherapy setting.

Phase I Ulcerative Colitis trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The decision to terminate study WP40161 was based on that treatment with RO7049665 showed trends in efficacy, however these data were below expectations and would not have supported superiority over standard of care.

Phase III Alzheimer Disease trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early-stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).

Phase IV Multiple Sclerosis trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Due to deterioration of the geopolitical situation and escalation of conflict between Russia and Ukraine ML42302 study was put on hold.

Phase III Neovascular Age-Related Macular Degeneration trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

Roche/Genentech has initiated an immediate pause of all new PDS implantations because the implants from commercial supply in the clinical studies did not meet the filed specifications for the intended use

Phase III Alzheimer Disease trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).

Phase III Alzheimer Disease trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I\&II (WN29922/WN39658).

Phase III COVID-19 trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Based on program revaluation and in agreement with the co-development partner the sponsor took the decision to terminate this study.

Phase III Medullary Thyroid Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Due to several logistical challenges during start-up which could not be overcome study was withdrawn.

Phase I Colorectal Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The Sponsor made the decision to terminate the study due to start up and recruitment issues caused by limited resource availability at the treating centers.

Phase II Carcinoma, Small Cell Lung trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The sponsor's decision was based on the negative results of SKYSCRAPER-02.

Phase I Castration-Resistant Prostatic Cancer trial by Hoffmann-La Roche. Stop reason: SAFETY.

Despite many risk-minimization strategies, the combination of ipatasertib, atezolizumab and docetaxel was challenging due to multiple study treatment modifications required to manage toxicity, making further enrollment inappropriate.

Phase II Autoimmune Hepatitis trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

A lack of efficacy was seen with RO7049665 in a study of ulcerative colitis. This reduces the likelihood that the drug is effective in autoimmune hepatitis.

Phase II Acute Ischemic Stroke trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision

Phase II Neoplasms trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The data from this study is no longer needed.

Phase I Solid Tumors trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was terminated due to program discontinuation.

Phase III Renal Cell Carcinoma trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The sponsor decided to terminate this study before the protocol-defined end-of-study, as permitted per protocol.

Phase III Carcinoma, Transitional Cell trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

Sponsor decided to terminate the study early because the study did not meet its primary endpoint and because the study had met its goals of providing safety and additional exploratory efficacy information for atezolizumab monotherapy in MIBC.

Phase II Breast Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision

Phase III Diffuse, Large B-Cell, Lymphoma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision, no safety concerns

Phase II Advanced/Metastatic Head and Neck, Oesophageal and Cervical Cancers trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.

Phase III Guillain-Barré Syndrome trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

This study has been withdrawn due to an internal decision. The decision was not due to any safety concerns with study drug.

Phase III Advanced BRAFV600 Wild-type Melanoma trial by Hoffmann-La Roche. Stop reason: SAFETY.

This study was terminated due to benefit/risk analysis.

Phase III Breast Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The Sponsor discontinued the manufacturing and development of taselisib due to modest clinical benefit and limited tolerability.

Phase II Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision, no safety concerns.

Phase I Acute Myeloid Leukemia trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.

Phase I Acute Myeloid Leukemia trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The Sponsor decided to discontinue the development of atezolizumab in combination with magrolimab in the AML indication.

Phase I Autism Spectrum Disorder trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study is on hold due to stopping of the Autism Spectrum Disorder program with balovatpan, the study drug.

Phase III Leukemia, Myeloid, Acute trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.

Phase II Polycythemia Vera trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The Sponsor decided to discontinue the development of idasanutlin in the polycythemia vera indication.

Phase I Follicular Lymphoma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.

Phase I Breast Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the CO41863 study.

Phase I Small Cell Lung Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the GO41864 study.

Phase I Bladder Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was terminated early as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.

Phase III Autism Spectrum Disorder trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

A futility analysis assessed that the study is highly unlikely to meet the pre-defined primary objective of the study. No new safety concerns were identified.

Phase II Carcinoma, Non-Small Cell Lung trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The positive results from IMpower010 demonstrated benefit by adding atezolizumab as adjuvant therapy in early stage NSCLC. These results raised ethical concerns of enrolling pts to best supportive care over checkpoint inhibition in this setting.

Phase I Hepatitis B Virus Infection trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was terminated due to program discontinuation.

Phase I B-Cell Chronic Lymphocytic Leukemia trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

This study was terminated early because premedication with tocilizumab was unlikely to reduce the risk of IRR.

Phase II Autism Spectrum Disorder trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The 24-week analysis indicated no clinical or statistical benefit for the primary endpoint for the overall study population. No new safety concerns identified.

Phase II Non-small Cell Lung Cancer (NSCLC) trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Accrual timelines

Phase II Sarcoma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

The study was closed to further enrollment due to the decision by the Sponsor to discontinue development of R1507.

Phase II Breast Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The sponsor decided to terminate study after 70% of participants had experienced a progression-free survival event.

Phase II Non-Squamous Non-Small Cell Lung Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

The study was terminated due to the termination of the clinical development program.

Phase II Breast Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Due to the discontinuation of compound development, this study has been terminated.

Phase I Advanced Ovarian Cancer trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Portfolio prioritization

Phase I Muscular Dystrophy (DMD) trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

A pre-planned futility analysis indicated lack of efficacy in study NCT03039686 and led to discontinuation of both ongoing studies in DMD.

Phase I Autism Spectrum Disorder trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Recent analysis of Phase II balovaptan data in paediatric ASD did not support the continuation of this study. No new safety concerns were identified.

Phase I Solid Tumors trial by Hoffmann-La Roche. Stop reason: SAFETY.

Study terminated due to change in benefit-risk ratio, driven by high incidence GI toxicity in absence of clinically significant anti-tumor efficacy.

Phase III Alzheimer's Disease trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.

Phase III Alzheimer's Disease trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

This study was discontinued due to an interim analysis in this study, which indicated that Crenezumab was unlikely to meet its primary endpoint.

Phase III Alzheimer's Disease trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.

Phase I Non-Hodgkin's Lymphoma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision to terminate the study after Phase 1; will not proceed with Phase 2.

Phase II Colorectal Cancer trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Cardiovascular Disease trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

Termination of the clinical development program by the Sponsor

Phase I Solid Tumor trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor decision to terminate because limited investigational agent activity was observed.

Phase II Rheumatoid Arthritis trial by Hoffmann-La Roche. Stop reason: EFFICACY/FUTILITY.

The trial was prematurely terminated due to a lack of efficacy of the investigational drug.

Phase III Geographic Atrophy trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase III Geographic Atrophy trial by Hoffmann-La Roche. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Early Phase I Advanced or Metastatic Solid Tumors trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor's decision

Phase I Solid Tumor trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Company decision