On April 14, 2019, the FDA approved Keytruda® as first line monotherapy for non-small cell lung, NSCLC, cancer patients whose cancer cells express PD-L1 and have no genomic changes in EGFR or ALK. In addition, the disease should be either stage III (localized lung cancer) and not operable or treatable with chemoradiation or stage IV (metastatic lung cancer).
The approval is based on results from the phase III clinical trial called KEYNOTE-042. The results demonstrated that Keytruda® monotherapy extended life statistically significantly compared with chemotherapy alone in patients whose tumors expressed PD-L1.
KEYNOTE-042 was a randomized and multi-center clinical trial in which non-small cell lung, NSCLC, cancer patients whose cancer cells express PD-L1 and have no genomic changes in EGFR or ALK could be enrolled. In addition, the disease should be either stage III (localized lung cancer) and not operable or treatable with chemoradiation or stage IV (metastatic lung cancer).
The study enrolled 1,274 patients who were divided to two groups in a 1:1 ratio to receive Keytruda® 200 mg every 3 weeks or physician’s choice of either of the following chemotherapy regimens:
Alimta® and Carboplatin for a maximum of six cycles followed by optional Alimta® for patients with nonsquamous (sub-type of NSCLC) or Taxol and Carboplatin for a maximum of 6 cycles followed by optional Alimta® for patients with nonsquamous (sub-type of NSCLC).
Treatment with Keytruda® continued until progression of disease, unacceptable toxicity or a maximum of 24 months.
All patients who were treated with Keytruda® benefited from it compared to patients who were treated with chemotherapy: They experienced an extended life prolongation.
Keytruda® was discontinued for side effects in 19 percent of 636 patients. The most common side effects resulting in permanent discontinuation of Keytruda® were pneumonitis, death and pneumonia.
Participation in a clinical trial is a great opportunity for cancer patients to benefit from the most advanced treatments in the world years before their final approval. Do not miss it.
Few words on Keytruda®
Cancer cells use a certain path to hide from the immune system cells, called “T cells”. Keytruda® helps prevent cancer cells from hiding.
Keytruda® is not chemo or radiation therapy as many might think. It is an immunotherapy which means it activates the immune system against certain cancer types, like lung cancer and melanoma, by making it attacking the cancer cells.
When T cells attack cancer cells they stop cancer cells from growing and spreading in the body.
Keytruda® can cause the immune system to attack normal organs and tissues in the body and can affect their functionality. These problems can sometimes become severe or life-threatening and can lead to death. These problems may also happen anytime during the treatment with Keytruda® or after it has ended.
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For further reading>>
https://journals.lww.com/oncology-times/blog/fdaactionsandupdates/pages/post.aspx?PostID=336&sid=faeda451-5935-4593-af51-d6398475fac9
