PALOMA-2 is assessing subcutaneous amivantamab. In this cohort it was subcutaneous amivantamab plus lazertinib in the first-line treatment for patients with common EGFR mutations. This is related to the MARIPOSA trial – IV amivantamab plus lazertinib demonstrating the benefit of this combination versus osimertinib with a median PFS of 24 months.

Now in this cohort we look at subcutaneous amivantamab plus lazertinib, subcutaneous amivantamab every two weeks. We have data from the PALOMA-3 trial showing the same pharmacokinetics for IV versus subcue but it’s important to see the actual data in the first-line setting. I have to say that the results are really good because we have a high response rate, 85%, we have a prolonged median PFS – nearly 28 months, so even higher than in the landmark MARIPOSA trial, and nearly 90% of the patients being alive at 18 months.

So clearly subcue is doing really good, even probably maybe better than IV. Maybe this is also because the adverse event profile is actually better with subcue. In this cohort we also had a systematic prophylactic anticoagulation to avoid venous thromboembolism and clearly there was only one patient with venous thromboembolism. So with the subcutaneous formulation we are reducing the risk of administration-related reactions that are quite frequent with IV formulation, even if you use a prophylactic steroid. In this study there was no systematic dermatologic prophylactic regimen but investigators were aware about the cutaneous side effects.

So it shows that with this combination, moving now with subcutaneous amivantamab we probably can do better when having all these prophylactic measures that were not implemented in the MARIPOSA trial, the landmark trial, because everything went at the same time. But now that we have subcue formulation to reduce infusion-related reactions, dermatologic prophylactic regimens with the COCOON regimen, prophylactic anticoagulation, I feel that this regimen is clearly easier to administer to the patient.

We have also seen last year data with amivantamab subcutaneous every four weeks which even facilitates a patient journey.

What’s next for the study?

What is next? Subcutaneous amivantamab has been made available in the US, in China, in Europe, it’s approved so now it’s a matter of implementing this. Not only at the hospital but also maybe thinking in some patients to the possibility to administer amivantamab at home which would even be better for the quality of life of the patients.