The FDA approved Keytruda for the treatment of patients with early renal cell carcinoma. The most common type of kidney cancer, with high or intermediate-high risk of recurrence after surgery. Merck said Thursday.
PD-1 inhibitor for kidney cancer is the first immunotherapy to enter the field
Keytruda could raise about $ 1.2 billion in peak sales from this kidney cancer adjuvant setting. Which could mean $ 3.4 billion for all PD-1 / L1 inhibitors. SVB Leerink analyst Daina Graybosch, Ph.D., recently told Fierce Pharma.
Before the advent of Keytruda, Pfizer’s kinase inhibitor Sutent had been approved since 2017 as adjunctive therapy to prevent recurrence of kidney cancer in high-risk patients. But treatment has not become the standard of care due to its limited effectiveness and a high rate of side effects.
In the phase 3 KEYNOTE-564 trial, Keytruda reduced the risk of disease recurrence or death by 32% over placebo. This when used as adjunctive therapy for intermediate-high or high risk kidney cancer. According to the data revealed in the American Society of the United States this year. Virtual meeting of Clinical Oncology.
The ideal patient population for this use of Keytruda continues to be debated.
But as Graybosch pointed out in a September note to clients, the ideal patient population for this use of Keytruda is still up for debate. Among patients in stage M0. Meaning that there is no distant cancer spread, Keytruda adjuvant only confers a relatively small benefit in disease-free survival. With a risk reduction of 26%. In contrast, the M1 population with completed resected metastases enjoyed a 71% risk reduction with Keytruda.
Since M0 patients already have a low risk of recurrence after surgical removal of the kidney. Prolonged adjuvant treatment with anti-PD-1, thanks to its toxicity. It may not be a good treatment strategy in the eyes of doctors, Graybosch added.
The latest adjuvant nod follows an August nod for Keytruda in combination with the Lenvima associated with Eisai in newly diagnosed advanced kidney cancer. As more advanced or metastatic cancer fields become saturated, current PD-1 / L1 players are looking more at early stage disease settings. Where treatments are adopted around surgery.
Doctors seem hesitant about the idea of adjuvant PD-1 / L1 treatment
For adjuvant kidney cancer, Keytruda could soon count on Roche’s Tecentriq company. The phase 3 trial IMmotion010 of the PD-L1 inhibitor has a primary end date of January 2022.
Last month, Tecentriq became the first in the PD-1 / L1 class to enter postoperative non-small cell lung cancer with an FDA clearance in patients with stages II to IIIA, PD-L1 positive. But the drug’s mediocre performance in patients with PD-L1 expression between 1% and 49% also surprised some.
Additionally, clinicians appear to be hesitant about the idea of adjuvant PD-1 / L1 treatment for lung cancer while awaiting readings on other drugs and more mature data on patient survival. Keytruda’s adjuvant NSCLC trial, named Keynote-091, is expected to be read next year.
Related Notes:
Five strategies for a more vital medical practice
GRAPH: These are the states with the worst health services
Regional Hospital Lic. Adolfo López Mateos; certified by the General Health Council