Ramucirumab-gemcitabine combination confers OS benefit in malignant pleural mesothelioma
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The addition of ramucirumab to gemcitabine significantly improved survival among patients with malignant pleural mesothelioma, according to randomized phase 2 study results presented during the ASCO20 Virtual Scientific Program.
“Unfortunately, the lack of therapeutic resources has led us to [intensify] the search for new therapeutic combinations in pleural mesothelioma,” Maria Pagano, MD, oncologist in the department of oncology and advanced technologies at General Hospital Arcispedale Santa Maria Nuova — Reggio Emilia in Italy, told Healio. “These positive data may be the beginning to change the clinical practice in the choice of second-line therapy of pleural mesothelioma.”
Pagano and colleagues conducted the multicenter, double-blind RAMES study to explore the safety and efficacy of ramucirumab (Cyramza, Eli Lilly), a fully human monoclonal antibody and VEGFR2 antagonist, combined with gemcitabine as second-line treatment for patients with malignant pleural mesothelioma who previously received platinum/pemetrexed regimens.
Researchers randomly assigned 161 patients (median age, 69 years; range, 44-81) to 1,000 mg/m² IV gemcitabine on days 1 and 8 of each 21-day cycle with either placebo (Arm A; n = 81) or 10 mg/kg IV ramucirumab (Arm B; n = 80) on day 1. Treatment continued until disease progression or tolerability.
Most patients (73.9%) were men, 59.6% had an ECOG performance status of 0 and 81.9% had an epithelioid histotype.
Researchers grouped patients according to age ( 70 years vs. > 70 years), ECOG performance status (0 to 1 vs. 2), histology (epithelioid vs. non-epithelioid) and time to progression following first-line therapy.
OS served as the primary endpoint.
Median number of treatment courses was 3.5 in Arm A and 7.5 in Arm B.
Results showed ramucirumab plus gemcitabine significantly extended OS compared with gemcitabine alone (13.8 months vs. 7.5 months; HR = 0.71; 70% CI, 0.59-0.85).
OS rates favored ramucirumab at 6 months (74.7% vs. 63.9%) and 1 year (56.5% vs. 33.9%).
OS in the ramucirumab group did not appear associated with time to progression after first-line therapy (13.6 months among those with time to progression of 6 months or less vs. 13.9 months among those with time to progression of 6 months or longer) or histotypes (13.8 months for epithelioid vs. 13 months for nonepithelioid).
Researchers also reported longer median PFS (6.2 months vs. 3.3 months) and longer duration of response (8.4 months vs. 5.4 months) in the ramucirumab group.
Five patients in the ramucirumab group experienced grade 3 to grade 4 hypertension (P = .022).
“Ramucirumab plus gemcitabine combination can represent a new option in the second-line treatment of patients with malignant pleural mesothelioma,” Pagano said. “Correlation of the response to treatments with the genetic and bioumoral profile of patients is ongoing to identify predictive response markers.” – by Jennifer Southall
Reference:
Pagano M., et al. Abstract 9004. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
Disclosures: Pagano reports no relevant financial disclosures. Please see the abstract for all other researchers’ relevant financial disclosures.
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Pagano M., et al. Abstract 9004. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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