These data, which were released in a late-breaking poster presentation at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO), which closed this Tuesday in Chicago, showed a rate of Comparable response in patients treated with amivantamab SC and lazertinib and in the treaties with the intravenous formulation (IV) in the MARIPOSA study.
The SC formulation of amivantamab was associated with a lower rate of infusion-related reactions -15 percent of all grades compared to 63 percent- and a shorter administration time than with formulation IV.
“The safety and tolerability data from the PALOMA-2 study highlight the potential of the subcutaneous formulation of amivantamab as an important first-line treatment for patients with lung cancer with EGFR mutation“said Kiran Patel, vice president of Solid Tumor Clinical Development at Johnson & Johnson Innovative Medicine.
Fewer reactions
“With a favorable tolerability profile thanks to fewer infusion-related reactions, this formulation can resolve an unmet need currently in the treatment of lung cancer with mutated EGFR,” added Nicolas Girard, director of Medical Oncology at the Institut Curie, and author of the study.
In the PALOMA-2 study, cohorts 1 and 6 included patients with treatment-naive advanced NSCLC with EGFR ex19del or L858R mutations, a patient population similar to that of the MARIPOSA study. In Cohort 1, the use of prophylactic anticoagulation and, in cohort 6, it was mandatory.
As of January 6, 2024, 68 and 58 patients had been enrolled in cohorts 1 and 6, respectively.1 After a median follow-up of 8.6 months, taking into account all patients, the SC formulation of amivantamab combined with lazertinib demonstrated an overall response rate (ORR) of 77 percent (confidence interval [IC] of 95 percent, 68-84) according to researcher evaluation using RECIST v1 criteria (primary endpoint) and 79 percent (95 percent CI, 70-86) as assessed by blinded independent central review.
Less administration time
A similar ORR of 86 percent (95 percent CI, 83-89) was seen with IV amivantamab in combination with lazertinib, as determined by a blinded independent central evaluation in the phase 3 MARIPOSA study. The average administration time was approximately five minutes compared to the 2-4 hours of intravenous administration. The median duration of response was not estimable in either cohort.
“These results in patients with EGFR-mutated lung cancer show that the efficacy profile of subcutaneous amivantamab is consistent with that of the IV formulation and, furthermore, could represent a more convenient option for patients and their caregivers“said Henar Hevia, director of the Oncology Area for Europe, Africa and the Middle East at Johnson & Johnson Innovative Medicine.
The joint analysis of cohorts 1 and 6 showed that the safety profile of amivantamab SC was consistent with that previously published, with no new safety signals identified. The most common adverse events (≥ 20 percent) due to treatment were paronychia (71 percent), rash (61 percent), and hypoalbuminemia (48 percent).
Improve patient experience
They were notified infusion-related reactions in 15 percent of patients between the two cohorts. Approximately 9 percent of all patients discontinued all medications due to treatment-related adverse events. Prophylactic anticoagulation was administered to 71 percent of Cohort 1 patients and 100 percent of Cohort 1 patients.
Additionally, venous thromboembolism (VTE) was reported in 18 and 7 patients in cohorts 1 and 6, respectively, with no dose reductions or discontinuations reported due to VTE. These results suggest that prophylactic anticoagulation can be implemented and thus reduce the incidence of VTE with the combination of amivantamab and lazertinib.
“At J&J, we are directing our efforts in those areas where we believe we could truly transform cancer treatment, including optimizing the treatment experience for patients“, Hevia stressed. “As we advance our solid portfolio of products for lung cancer patients, we remain committed to developing effective treatments that can offer clear benefits in the treatment of this disease,” he said along the same lines. Patel.
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