The good news
The Food and Drug Administration (FDA) has approved amivantamab to be given under the skin, which is called a subcutaneous (SQ) injection, for adult patients with the same conditions where amivantamab is already approved to be given through a vein, or intravenously (IV).
Why it’s important
Amivantamab is a type of treatment called a bispecific antibody, which means that it has two different targets, EGFR and MET. It has been approved for the treatment of non-small cell lung cancer (NSCLC) in several situations:
- For NSCLC with EGFR exon 20 insertion mutations, it can be used in combination with chemotherapy as initial treatment, or on its own if disease has progressed on chemotherapy.
- For NSCLC with common EGFR mutations (exons 19 and 21), it can be used in combination with lazertinib as initial treatment, or in combination with chemotherapy if the disease has progressed after treatment with an EGFR targeted therapy (usually osimertinib).
The SQ injection of amivantamab was evaluated in the PALOMA-3 trial. Over 400 patients with advanced NSCLC and common EGFR mutations received either SQ or IV amivantamab in combination with lazertinib.
The trial showed that patients who received SQ amivantamab had similar treatment responses and survival outcomes as patients who received IV amivantamab.
What it means for patients
An important consideration for patients is safety and convenience. The safety profile of the SQ amivantamab was generally similar to the safety profile of the IV amivantamab, with one exception. Infusion reactions occurred less often for SQ amivantamab (13% of patients) compared to those who received IV amivantamab (66% of patients).
Other side effects with either form of amivantamab could still include interstitial lung disease/pneumonitis, venous thromboembolic events when used with lazertinib, skin rash, ocular toxicity, and embryo-fetal toxicity.
Another important factor is that the SQ administration allows patients to spend less time at their doctor’s office receiving amivantamab, which contributes to their overall quality of life.
What to look for
The SQ administration of amivantamab is likely to replace the IV administration of the drug in most circumstances and could be employed in clinical trials as well. Research that is geared toward reducing side effects and changing drug administration in order to improve a patient’s quality of life is very important. It is likely that there will be more clinical trials evaluating other treatments with the sole purpose of reducing side effects and decreasing the time that patients spend getting their treatments.