Yes, Inlyta (axitinib) is used in combination with Keytruda (pembrolizumab) to treat advanced renal cell carcinoma (RCC).
FDA Approval for the Combination
The FDA approved Keytruda plus Inlyta in April 2019 as first-line treatment for adults with advanced RCC, based on the phase 3 KEYNOTE-426 trial. This showed the combo reduced death risk by 35% and disease progression by 48% compared to sunitinib.[1][2]
How the Combination Works
Keytruda, a PD-1 inhibitor, boosts the immune response against cancer cells. Inlyta, a VEGF tyrosine kinase inhibitor, blocks blood vessel growth to tumors. Together, they target both immune evasion and angiogenesis in RCC.[1]
Clinical Trial Results
In KEYNOTE-426 (n=861 patients), the combo had a median progression-free survival of 15.1 months versus 11.1 months for sunitinib, and overall survival favored the combo (hazard ratio 0.66).[2] Updated data through 2023 confirm sustained benefits.[3]
Who Makes These Drugs
Keytruda is from Merck & Co. Inlyta is from Pfizer.[1]
Common Side Effects in Combo
Hypertension (56%), diarrhea (39%), hypothyroidism (34%), fatigue (32%), and hepatotoxicity occur frequently. Immune-related adverse events like colitis or pneumonitis affect about 20%.[2][4]
Alternatives and Comparisons
- With other combos: Similar to Keytruda + Lenvima (lenvatinib) for RCC, but KEYNOTE-426 positioned Keytruda/Inlyta as a standard.
- Competitors: Opdivo (nivolumab) + Yervoy (ipilimumab) or Cabometyx (cabozantinib) + Opdivo are other first-line options, with varying efficacy profiles.[3]
No biosimilars yet for either drug.
Patent Status
Inlyta's key composition patent (US 6,608,061) expired in 2022 in the US, but method-of-use patents extend protection into the late 2020s. Keytruda's main patents run until 2028, with extensions possible.[5]
[1]: FDA.gov - Approval Summary for Pembrolizumab/Axitinib (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-plus-axitinib-advanced-renal-cell-carcinoma)
[2]: NEJM - Pembrolizumab plus Axitinib vs Sunitinib (https://www.nejm.org/doi/full/10.1056/NEJMoa1816714)
[3]: Lancet Oncology - KEYNOTE-426 4-Year Update (https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00272-1/fulltext)
[4]: Keytruda Prescribing Information (https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf)
[5]: DrugPatentWatch.com - Inlyta Patents (https://www.drugpatentwatch.com/p/tradename/INLYTA)