Keytruda® for Adult and Pediatric Patients with Classical Hodgkins Lymphoma
by Dr. C.H. Weaver M.D. 5/2020
The U.S. Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab), an anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (HL) in 2018. Since FDA approval researchers continue to evaluate how best to use Keytruda immunotherapy in the overall management of HL.
Hodgkin’s lymphoma is a cancer of the lymph system. It typically begins in the lymph nodes in one region of the body and then spreads throughout the lymph system. Hodgkin’s lymphoma is one of the more curable cancers with effective treatments available at several stages of disease. Some patients with relapsed or refractory HL may also be cured with high doses of chemotherapy and stem cell transplant. For patients that fail stem cell transplant additional treatment options are limited.
Keytruda® is a monoclonal antibody that helps to restore the body’s immune system in fighting cancer. It creates its anti-cancer effects by blocking a specific protein used by cancer cells called PD-L1, to escape an attack by the immune system. Once PD-L1 is blocked, cells of the immune system are able to identify cancer cells as a threat, and initiate an attack to destroy the cancer. Keytruda® is approved for the treatment of certain types of metastatic melanoma and head and neck cancer.
The initial FDA approval was based on data in 210 patients from the KEYNOTE-087 clinical trial, which demonstrated an overall response rate with of 69% with a complete remission rate of 22% and a partial remission rate of 47% in patients with advanced - recurrent HL. Among the 145 responding patients, the median duration of response was 11.1 months.
KEYNOTE-204 Keytruda Superior to Adcetris
The KEYNOTE-204 clinical trial compared Keytruda to Adcetris in patients with relapsed or refractory classic Hodgkin lymphoma. Results of the study were presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program in May 2020.
A total of 300 patients were treated with either Keytruda or Adcetris as the sole therapy for their recurrent HL and directly compared. All patients had received prior autologous stem cell transplant or were ineligible for such transplant After a median follow-up of 24.7 months 54% of patients treated with Keytruda survived without evidence of lymphoma progression compared to 35% of those treated with Adcetris. Importantly there was also a lower incidence of serious treatment related side effects with Keytruda.
The results from KEYNOTE-087 and 204 demonstrate that most patients with relapsed or refractory classical Hodgkin lymphoma respond to treatment with Keytruda. Keytruda represents an effective and well tolerated treatment option for individuals with recurrent-refractory HL who fail or are unable to undergo curative therapy with ASCT.