In short
Lenalidomide hydrochloride hydrate is an immunomodulating agent used in the treatment of certain blood cancers, including multiple myeloma and follicular lymphoma. It is authorised in the European Union as a generic of Revlimid, which has been available since 2007. The clinical trial data contains one Phase 1 study (NCT04623541) with 203 enrolled participants, where lenalidomide is used as a combination therapy arm in relapsed/refractory chronic lymphocytic leukemia and Richter's syndrome.
Key points
- Lenalidomide is an immunomodulating agent authorised for multiple myeloma and follicular lymphoma in the EU.
- The registered trial is a Phase 1 study in relapsed/refractory chronic lymphocytic leukemia and Richter's syndrome.
- The trial enrolled 203 participants and is currently authorised.
- Lenalidomide is given as oral capsules in strengths from 2.5 mg to 25 mg.
- The trial measures objective response rate and safety endpoints including dose-limiting toxicities.
- The substance is a derivative of thalidomide with teratogenic potential requiring a risk management plan.
What is lenalidomide hydrochloride hydrate?
Lenalidomide hydrochloride hydrate is an immunomodulating agent. The European Medicines Agency (EMA) describes the active substance lenalidomide as working in several ways, including through cytokine modulation, induction of T-cell proliferation, anti-proliferation of multiple myeloma cells, and inhibition of angiogenesis. It is a derivative of thalidomide.
Lenalidomide Krka, a medicine containing lenalidomide, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 10 December 2020. It is a generic of Revlimid, which has been authorised in the EU since 14 June 2007.
How does lenalidomide hydrochloride hydrate work?
Lenalidomide works as an immunomodulating agent through multiple mechanisms. These include modulation of cytokines, induction of T-cell proliferation, direct anti-proliferative effects on multiple myeloma cells, and inhibition of angiogenesis, which is the formation of new blood vessels that tumours need to grow.
Which conditions is it used or studied for?
- Multiple myeloma — lenalidomide is authorised as monotherapy for maintenance treatment after autologous stem cell transplantation, and in combination with dexamethasone, bortezomib and dexamethasone, or melphalan and prednisone for previously untreated patients who are not eligible for transplant. It is also indicated with dexamethasone for patients who have received at least one prior therapy.
- Follicular lymphoma — lenalidomide is authorised for this condition in the EU.
- Chronic lymphocytic leukemia — the registered clinical trial investigates lenalidomide in combination with epcoritamab for relapsed/refractory chronic lymphocytic leukemia.
- Richter's syndrome — the same trial studies lenalidomide in combination with epcoritamab for Richter's syndrome.
How is lenalidomide hydrochloride hydrate given?
Lenalidomide is available as hard capsules in strengths of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg. In the registered clinical trial, lenalidomide is listed as an oral drug.
What do the clinical trials show?
One trial is registered for lenalidomide hydrochloride hydrate in the provided data. The trial NCT04623541 is a Phase 1 interventional study investigating epcoritamab in subjects with relapsed/refractory chronic lymphocytic leukemia and Richter's syndrome, with lenalidomide included as a combination therapy arm.
Who can take part in these trials?
The trial enrolled 203 participants with relapsed/refractory chronic lymphocytic leukemia or Richter's syndrome. The study includes both monotherapy cohorts and combination therapy cohorts with venetoclax, lenalidomide or R-CHOP.
What are the trials measuring?
The primary outcomes include the incidence of dose-limiting toxicities, adverse events and serious adverse events, as well as objective response rate assessed by an independent review committee in the expansion cohorts. For the lenalidomide combination arm in Richter's syndrome, the objective response rate is assessed by the independent review committee.
What is the status of these trials?
The trial is authorised and is an interventional study.
What side effects are known?
The EMA catalogue describes a database study of lenalidomide in Germany that was required as part of a risk management plan due to the teratogenic potential of the drug. Teratogenic potential means the medicine can cause harm to a developing fetus. The study monitored off-label use of lenalidomide based on claims data from around 14 million enrollees.