Additional data from a phase III open-label study, presented at conference, demonstrated that early treatment with lenalidomide (Revlimid™) and dexamethasone followed by continuous lenalidomide delayed time to symptomatic disease and demonstrated a survival advantage compared with observation (current standard of care)..

Of 119 evaluable patients, 57 were treated with lenalidomide (25 mg daily on days 1-21 of a 28-day cycle) and dexamethasone (20 mg on days 1-4 and 12-15 of a 28-day cycle) for nine four-week cycles and then continued treatment with a lower dose of lenalidomide (10 mg daily on days 1-21 of a 28-day cycle) until disease progression, while there were 62 patients in the therapeutic abstention arm.

After a median follow-up of 22 months, the following results were presented:

• 9 of 57 (15%) patients progressed to symptomatic disease in the treatment arm. In addition, 14 patients developed biological progression during maintenance, and dexamethasone was added according to protocol, with 10 of these patients subsequently achieving disease control.

• In the abstention arm, 37 of 61 patients (59%) progressed to active multiple myeloma.

• The median time to progression (TTP) from inclusion was 23 months for the delayed treatment arm, while the median TTP has not been reached in the treatment arm (p<0.0001) (HR 6.0; 95% CI=2.9-12.6).

• Of note, 20 of the 37 patients in the abstention arm whose disease progressed developed bone lesions as a symptom of active multiple myeloma.

• Three-year overall survival (OS) from inclusion was 93% for the treatment arm and 76% for the abstention arm (p=0.04).

• There were no reports of grade 4 adverse events. Grade 3 adverse events during induction included asthenia (7%, 4/57), diarrhoea (4%, 2/57), infection (2%, 1/57), anaemia (2%, 1/57) and skin rash (2%, 1/57).

• Three patients in the treatment arm developed second primary malignancies (SPM). One developed polycythemia vera JAK2+ during treatment, but an analysis of a frozen DNA sample obtained at the time of screening showed that the patient was already JAK2+ at enrolment. The second two SPMs were prostate cancer in patients with previous history of prostate enlargement plus elevated prostate specific antigen (PSA).

In The UK, lenalidomide is licensed in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. It is not licensed for high-risk smoldering multiple myeloma.