Biomarkers associated with response to monotherapy compared to combination therapy in cancers

Lead Investigator: Vitalay Fomin, Y-AI inc.
Title of Proposal Research: Biomarkers associated with response to monotherapy compared to combination therapy in cancers
Vivli Data Request: 9121
Funding Source: None
Potential Conflicts of Interest: For the tools, we will use only Genentech data and are not developing tools based on their data, we are developing tools on public datasets and validating on on the clinical trials data here. In addition, the data agreements state that we must notify Genentech first about any discovery and they have the right to decide what to do with the findings. So I can confirm there will be no COI.

Summary of the Proposed Research:

Cancer affects around 18 million people worldwide. Unfortunately, for many types of cancer, no effective therapies exist. Even for cancers with available treatments, the majority of patients do not respond. Furthermore, we lack the ability to accurately identify and understand which patients will benefit most from specific therapies. Some progressing patients might benefit greatly from one therapy but not another.

Therefore, it’s crucial to identify factors that can predict and help us understand which patients will benefit from which treatment. This would prevent assigning ineffective or potentially harmful therapies. We plan to use data from lung, bladder, skin, and kidney cancer to investigate how factors like age, type of medication, smoking history, and lab results might predict treatment response. To handle the complex nature of this data, which standard analysis techniques cannot address, we will employ advanced computational methods capable of analyzing massive patient datasets and predicting individual patient responses.

Requested Studies:

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02008227
Sponsor ID: GO28915

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Data Contributor: Roche
Study ID: NCT02108652
Sponsor ID: GO29293 (Cohort 2)

A Phase II, Multicenter, Single-Arm Study of Atezolizumab in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
Data Contributor: Roche
Study ID: NCT02951767
Sponsor ID: GO29293 (Cohort 1)

A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
Data Contributor: Roche
Study ID: NCT02908672
Sponsor ID: CO39262

A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma
Data Contributor: Roche
Study ID: NCT03434379
Sponsor ID: YO40245

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02367794
Sponsor ID: GO29437

A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy
Data Contributor: Roche
Study ID: NCT02302807
Sponsor ID: GO29294

A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma
Data Contributor: Roche
Study ID: NCT02420821
Sponsor ID: WO29637

A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Data Contributor: Roche
Study ID: NCT02366143
Sponsor ID: GO29436