Revlimid (lenalidomide) is a cancer immunotherapy that Celgene developed to treat hematologic cancers, which are cancers that begin in the tissues that form blood, such as bone marrow or in cells of the immune system.

Revlimid is used to treat patients with multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes. It also is being investigated as a treatment for follicular lymphoma.

How Revlimid works

Revlimid fights cancer through two mechanisms. One way is as an immunomodulatory therapy, meaning that it is capable of modifying and regulating certain functions of the immune system. For example, it stimulates the immune system to fight cancer, activating T-cells and increasing the tumor-killing effects of so-called natural killer (NK) cells.

Another way Revlimid fights cancer is an antiangiogenic therapy, meaning that it blocks the formation of new blood vessels around the tumor, preventing tumor growth.

Revlimid in clinical trials for follicular lymphoma

Revlimid initially showed effectiveness in patients with follicular lymphoma when given alone in a Phase 2 clinical trial (NCT00179673). The results of the trial showed that Revlimid produced durable responses (about 16.6 months) with manageable side effects.

Subsequently, the effect of the combination of Revlimid and Rituxan (rituximab) was tested. A Phase 2 trial (NCT00238238) called CALGB 50401 investigated 97 patients with follicular non-Hodgkin lymphoma who received Revlimid alone or in combination with Rituxan. Results showed that the combination was more effective than Revlimid alone, with 76 percent of patients responding to the combination and only 53 percent of patients responding to Revlimid alone. Complete responses were observed in 39 percent of patients who received the combination.

A Phase 3b trial (NCT01996865) called MAGNIFY is currently investigating the combination of Revlimid plus Rituxan in patients with follicular lymphoma, as well as marginal zone and mantle cell lymphoma, whose disease returned after a period of improvement or became resistant to treatment. An interim analysis of this trial was presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) and subsequently updated at the 2017 International Conference on Malignant Lymphoma (ICML). According to the analysis, the combination was well-tolerated and showed good clinical activity with 66 percent of patients responding to treatment. Patients with poor prognosis, including those who failed multiple therapies or whose disease returned early after an initial improvement, also responded to treatment. The trial continues to recruit participants at 110 study locations in the U.S., Germany, and Puerto Rico.

The results of another Phase 2 trial (NCT01145495) called CALGB 50803 were published in the medical journal Annals of Oncology. They showed that Revlimid combined with Rituxan is a safe and effective first treatment option for patients with follicular non-Hodgkin lymphoma. A total of 65 patients were included in the trial and followed for approximately five years. Ninety-five percent of them showed a response to treatment; 72 percent of them had a complete response (no sign of active disease). After five years, all patients were still alive, and 70 percent of them remained free from disease progression. The most common side effect observed was fatigue, and 21 percent of patients had very low levels of white blood cells (neutropenia).

An ongoing Phase 3 trial (NCT01476787) called RELEVANCE is comparing Revlimid plus Rituxan with chemotherapy plus Rituxan. Investigators are hopeful it will help clarify which of the two options is safer and more effective in follicular lymphoma patients. This study is no longer recruiting participants.

Another Phase 3 trial (NCT01938001) called AUGMENT is investigating the effect of Rituxan plus Revlimid, or Rituxan alone, in follicular lymphoma and marginal zone lymphoma patients. This trial also is ongoing, but not recruiting participants.

Several other trials are currently ongoing in patients with follicular lymphoma to investigate the effectiveness of Revlimid in combination with various other therapies, such as Gazyva (obinutuzumab – NCT02871219 and NCT01582776), Zydelig (idelalisib – NCT01644799) and Imbruvica (ibrutinib – (NCT02532257).

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Joana Cavaco Silva BNS Writer
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Joana Cavaco Silva BNS Writer