12:00 AM
Dec 14, 2015
 |  BioCentury  |  Product Development

Following CoMMpass

How a patient-run study is influencing R&D and treatment in myeloma

Amidst a flood of promising data for hot targets, indications and technologies at this year's American Society of Hematology meeting, one collection of presentations stands out not only for the wide-reaching implications of their data, but also for how the data came to be. It is now apparent that CoMMpass - a massive clinical study in multiple myeloma that was conceived of and is led by patients - is influencing what drugs are developed and will influence how they are used after approval.

The Multiple Myeloma Research Foundation (MMRF) launched CoMMpass in 2011 to identify molecular drivers in MM with the goal of discovering new drug targets and treatment combinations that could result in better outcomes. The trial is a public-private partnership with four industry members (see "Building CoMMpass," page 4).

Results reported at ASH represented the most robust data set yet for the trial, with seven abstracts and analyses derived from more than 700 patients. Among the key findings highlighted by MMRF, MM companies and clinicians was the identification of four previously described genes and targets as driver mutations in newly diagnosed patients.

The trial has also revealed genomic differences that could lead to targeted therapies for African-Americans, who are twice as likely to get MM; and findings related to disease burden and quality of life (see "Highlighting CoMMpass," page 4).

One MM company contacted by BioCentury is already using the data to evaluate new drug candidates, while other companies are querying the results to better understand how patients in their clinical trials might respond to drug candidates.

The CoMMpass data also will inform the treatment arms in a collaborative MM master protocol trial that is expected to begin next year.

But companies and doctors are most excited about future data from CoMMpass, which both groups believe will allow them to choose, sequence and combine established and newly approved therapies in the real world, as well as identify new drug candidates that could lead to a cure.

Early returns

CoMMpass is a sequencing study that is following 1,000 patients for eight years to determine how molecular profiles change with response and retreatment.

Patients have a bone marrow biopsy at study entry and each time their disease progresses. The biopsy is sequenced and investigators collect response data, including levels of minimal residual disease (MRD), as well as quality of life and toxicity data.

The protocol specifies first-line treatment with physician's choice of either doublet therapy - dexamethasone plus either an immunomodulatory agent or a proteasome inhibitor - or triplet therapy with all three types of agents. There is no specified treatment regimen after first relapse.

MMRF and its collaborators, including the Translational Genomics Research Institute (TGEN), analyze the data from CoMMpass every three months and conduct predetermined analyses based on work plans agreed to by an advisory board. The board includes MMRF, industry and academics.

Collaborators have exclusive access to the data for six months, after which the data are uploaded to an online portal that is available to the public.

CoMMpass hit its 1,000 patient target this September, and MMRF said enrollment in the international trial would be open through year end to allow up to 100 more patients to enroll.

This year's ASH presentations confirmed earlier findings and generated new hypotheses about what might be driving the disease.

The first interim look in 2013, consisting of one abstract including data from 178 patients, identified a handful of genes that were mutated frequently. These included BRAF; neuroblastoma Ras viral (v-Ras) oncogene...

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