E-Newsletter - December 2020
Spotlight on Alliance Trials

Alliance Investigators work to bring practice-changing treatment through registration trials

Currently, the Alliance has three active trials and one pending activation which have been developed for a planned New Drug Application (NDA, aka “registration”) submission to the U.S. Food and Drug Administration (FDA), after the primary study endpoint has been met and data has been released by the Alliance Data and Safety Monitoring Board (DSMB). An NDA is an application for sales and marketing approval of drug after enough data has been compiled to support the drug safety and efficacy, in the relevant disease indication.

Let’s take a look at these four Alliance trials.

The upcoming Alliance A011801 trial [CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib] is being led by Ciara C. O'Sullivan, MB, BCh, BAO, of the Mayo Clinic in Rochester, MN. In this phase III trial, Alliance investigators will study how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from relapsing in patients with high risk, HER2-positive early breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a targeted therapy because it attaches to specific molecules (or receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with high-risk HER2 positive early breast cancer compared to standard of care with T-DM1 alone.
ClinicalTrials.gov Identifier: NCT04457596

Alliance A021502 (Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC)) is being led by Frank Sinicrope, MD, of the Mayo Clinic in Rochester, MN. This active phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.
ClinicalTrials.gov Identifier: NCT02912559

Alliance A021602 (Randomized, double-blinded phase III study of cabozantinib versus placebo in patients with advanced neuroendocrine tumors after progression on prior therapy (CABINET)) is being led by Jennifer Chan, MD, MPH, of the Dana-Farber Cancer Institute. This active randomized phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that cannot be removed by surgery or spread to other places in the body (advanced). Cabozantinib is a tyrosine kinase inhibitor, a drug that targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
ClinicalTrials.gov Identifier: NCT03375320

Alliance A041701 (A randomized phase II/III study of conventional chemotherapy +/- GMI-1271 in older adults with de novo acute myeloid leukemia receiving intensive induction chemotherapy) is being led by Geoffrey L. Uy, MD, of Washington University in St. Louis. This active phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells. Uproleselan blocks a protein called E-selectin which helps protect tumor cells against chemotherapy. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.
ClinicalTrials.gov Identifier: NCT03701308



For other articles in this issue of the Alliance E-News newsletter, see below.