So this is PALOMA-2 study, multi-cohort study. Here this is a cohort of patients first line, common EGFR mutation, receiving amivantamab plus lazertinib, as we see in the landmark MARIPOSA trial. Mariposa has just been published in the New England Journal of Medicine, showing the benefit of the combination versus Osimertinib. How to move forward and integrate amivantamab subcutaneous in this regimen? This is a Paloma II cohort with amivantamab...
So this is PALOMA-2 study, multi-cohort study. Here this is a cohort of patients first line, common EGFR mutation, receiving amivantamab plus lazertinib, as we see in the landmark MARIPOSA trial. Mariposa has just been published in the New England Journal of Medicine, showing the benefit of the combination versus Osimertinib. How to move forward and integrate amivantamab subcutaneous in this regimen? This is a Paloma II cohort with amivantamab. Every four weeks, subcutaneous formulation and in combination with lazertinib, integrating the VTE prophylaxis for the first four months and also looking at the outcomes of patients. Exposure to amivantamab was actually similar as expected with the subcutaneous formulation. We have in this cohort of patients a response rate of 83%, very similar to that reported in Mariposa. We see prolonged responses in those patients, median not yet reached, So no duration of response yet, no PFS, no OS. In terms of safety, we see a very low risk of VTE, less than 10%. So in line with what is expected in this patient population. With the subcutaneous formulation of amivantamab, we see a very low risk of infusion-related reaction as expected. In this cohort, the cocoon regimen was not implemented for the dermatologic prophylactic management and we still see some cutaneous adverse events as expected. So this data really shows the value of the subcutaneous formulation of amivantamab, which will be very helpful for the patients, very helpful for the patient care organization at the hospital and support obviously the MARIPOSA regimen as the standard of care for patients with EGFR common mutation.
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