Stage 4 Squamous Cell Lung Cancer: Immunotherapy Receives FDA Approval for 1st-Line Treatment

On 30 October 2018, the United States Food and Drug Administration (FDA), for metastatic (stage 4) squamous cell lung cancer, first-line treatment, carboplatin plus paclitaxel or nab-paclitaxel in combination with pembrolizumab (Keytruda) , an immunotherapy drug, received approval.

The approval is based on a study involving previously untreated patients, regardless of the tumor's PD-L1 positivity status irrespective of this, a multicenter, double-blind, placebo-controlled study enrolling 559 patients with metastatic squamous non-small cell lung cancer, phase-3 clinical trial called KEYNOTE-407 .

Patients were randomly assigned to receive pembrolizumab 200 mg or placebo in combination with a doublet chemotherapy regimen. Treatment continued until cancer progression, unacceptable side effects or a maximum of 24 months.

The Most Noteworthy Results of the Study;

• Median overall survival was 15.9 and 11.3 months for the pembrolizumab plus chemotherapy and placebo plus chemotherapy arms, respectively. • Adding immunotherapy to chemotherapy reduced the risk of death by % 36.
• Median progression-free survival was 6.4 and 4.8 months for the pembrolizumab plus chemotherapy and placebo plus chemotherapy arms, respectively.
• Adding immunotherapy to chemotherapy reduced the risk of progression by % 44.
• Estimated median durations of treatment response were 7.2 and 4.9 months, respectively.

In the KEYNOTE-407 study, the most common side effects in at least % 20 of patients receiving pembrolizumab were; fatigue, nausea, constipation, diarrhea, vomiting, fever, loss of appetite, rash, cough, shortness of breath, alopecia (hair loss) and peripheral neuropathy .

Related Topic:

• What are the side effects of immunotherapy drugs, and how are they treated?

The recommended pembrolizumab for metastatic squamous lung cancer doseis every 3 weeks, on the same day as chemotherapy, at 200 mg intravenously (into a vein). Treatment is expected to continue until cancer progression, unacceptable side effects or up to 24 months.

• Details of the KEYNOTE-407 study