REVLIMID (lenalidomide) now available in UK for adult patients with previously untreated multiple myeloma who are not eligible for transplant

Celgene Limited, a wholly owned subsidiary of Celgene Corporation, has announced that REVLIMID (lenalidomide) is now available for adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplant. The availability of lenalidomide for first-line use in multiple myeloma is an important advance in the management of the disease, significantly improving progression-free survival (PFS) and overall survival (OS) rates when compared to the standard of care, in patients living with the condition as demonstrated in two pivotal studies.¹

Multiple myeloma is a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system.² It is a rare but deadly disease. In the United Kingdom, the lifetime risk of developing multiple myeloma is 1 in 120 for men and 1 in 155 for women, with approximately 4,800 new cases diagnosed each year.³ Out of 20 common cancers in England and Wales, the ten-year survival rate for multiple myeloma ranks sixth lowest overall with only 32.5% of patients surviving ten years post diagnosis.⁴ The median age of multiple myeloma diagnosis is 65-70 years of age⁵ and the majority of newly diagnosed patients may not be eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant.⁶

The licence is based on data from two pivotal phase III studies, MM-020 (also known as the FIRST trial) and MM-015.¹ These studies demonstrate the effectiveness of lenalidomide in improving PFS and OS in patients with newly diagnosed multiple myeloma when compared with current standard of care.

"Multiple myeloma is a severe haematological cancer that significantly impacts the lives of all patients diagnosed with the condition," said Professor Jamie Cavenagh, Consultant Haematologist at St Bartholomew's Hospital and lead UK investigator in the FIRST trial. "We know that lenalidomide is an effective treatment for multiple myeloma, so it's really exciting that it is now licensed to treat newly-diagnosed patients not eligible for transplant where the clinical trials have shown real benefit."

"The launch of Revlimid in the UK for newly diagnosed multiple myeloma is a real step forward for patients where currently there are limited treatment options," said Dr Adrian Kilcoyne, Medical Director, Celgene UK and Ireland. "This provides clinicians with an additional treatment option from the point of diagnosis, one that has been shown in pivotal trials to increase the rates of progression free survival and overall survival. Today's milestone reinforces Celgene's commitment to addressing unmet need and advancing treatments for multiple myeloma patients, and we hope that patients who may benefit from this important treatment will be able to access it as quickly as possible."

The European Commission decision to license lenalidomide in newly diagnosed adult multiple myeloma patients ineligible for transplantation follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in December 2014.

About MM-020 (also known as the FIRST trial)

The FIRST study, MM-020, published in the New England Journal of Medicine in 20141 was one of the largest phase III, multi-centre, open-label, randomised studies in patients newly diagnosed with multiple myeloma who were not eligible for stem cell transplantation. The study, which included 1,623 patients, compared lenalidomide plus dexamethasone administered in 28-day cycles (Rd) until disease progression, with Rd for 72 weeks (18 cycles; Rd18) and melphalan-prednisone-thalidomide (MPT) for 72 weeks. PFS (study primary endpoint) was significantly improved in patients treated continuously with Rd until disease progression, compared with those receiving MPT (primary comparison, p<0.0001) or Rd18 (p<0.0001). The median duration of PFS at the data cut-off on 3 March 2014 was 26.0 months with Rd vs. 21.9 months with MPT. Median OS in patients receiving Rd continuously until disease progression was 58.9 months, vs. 48.5 months for patients treated with MPT (HR 0.75; 95% CI 0.62, 0.90), based on a March 3, 2014 interim analysis. The numbers of patients experiencing any grade 3 or 4 adverse event were similar in each group. The most frequent grade 3 or 4 adverse events were neutropenia, anaemia and infections.

About MM-015

MM-0151 was a multi-centre, randomised, double-blind, placebo-controlled phase III study of 459 patients that compared melphalan-prednisone-lenalidomide induction followed by lenalidomide maintenance (MPR+R) with melphalan-prednisone-lenalidomide (MPR+p) or melphalan-prednisone (MPp+p) followed by placebo in patients ≥65 years or older with newly diagnosed multiple myeloma. PFS (study primary endpoint) was significantly improved in patients treated with MPR+R when compared with MPR+p and MPp+p (p<0.001 for comparisons of MPR+R over MPR+p and MPp+p). In the MM-015 study, OS was not significantly improved when compared across any treatment arm. During induction, the most frequent adverse events were haematologic (including neutropenia, thrombocytopenia, and anaemia). During the maintenance phase, the incidence of new or worsened grade 3 or 4 adverse events was low (0 to 6%).

About REVLIMID (lenalidomide)

In the European Union, lenalidomide is approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries.

Lenalidomide is also approved in Europe for the treatment of patients with transfusion- dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.