Ipsen Announces at ASCO 2022 New Cabometyx Data Show Encouraging Results in Monotherapy and in Combination Across Different Tumor Types
Ipsen announced encouraging data to be presented for the multi-targeted tyrosine kinase inhibitor (TKI), Cabometyx^® (cabozantinib), across a range of cancer types at this year’s American Society of Clinical Oncology Annual Meeting (ASCO 2022) to be held on 3-7 June. Data presentations will include findings in metastatic non-small cell lung cancer (NSCLC), as well as established indications of advanced renal cell carcinoma and radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). These data show that the therapeutic potential of Cabometyx as a key treatment option in a broad range of tumors is continuing to be realized. Updated outcomes from the multicenter Phase Ib COSMIC-021 trial evaluating the combination of Cabometyx plus atezolizumab in an expanded patient population in metastatic NSCLC demonstrate encouraging clinical activity with manageable toxicity in people previously treated with an immune checkpoint inhibitor (ICI).^1 These data lay the foundations for the potential of Cabometyx in metastatic NSCLC which is being further examined in the ongoing Phase III CONTACT-01 trial. This trial is evaluating the combination of Cabometyx plus atezolizumab vs docetaxel in patients with metastatic NSCLC previously treated with an ICI and platinum-containing chemotherapy, and topline results of the study are expected to be announced in the second half of 2022. An exploratory analysis will also be presented investigating the relationship between depth of response (DepOR) and clinical outcomes in CheckMate -9ER, evaluating Cabometyx in combination with nivolumab vs sunitinib in previously untreated advanced renal cell carcinoma.^2 DepOR was defined as the best percent reduction from baseline in sum of diameters of target lesions. Overall, greater proportions of patients receiving Cabometyx plus nivolumab demonstrated deeper responses vs sunitinib. Regardless of treatment, deeper responses were generally associated with improved progression-free survival (PFS) and overall survival.^2 Additionally, two new data analyses from the pivotal Phase III trial COSMIC-311 evaluating Cabometyx in RAI-R DTC will be presented. One analysis relates to outcomes for prespecified subgroups based on the baseline histology subtypes of papillary and follicular thyroid cancers, with results showing Cabometyx maintained superior efficacy vs placebo irrespective of histology subtype.^3 Median PFS was 9.2 months for Cabometyx vs 1.9 months for placebo in the papillary thyroid cancer (PTC) subgroup (HR 0.27 95% CI, 0.17-0.43) and 11.2 months vs 2.5 months in the follicular thyroid cancer (FTC) subgroup (HR 0.18 95% CI, 0.10-0.31). The overall response rate (ORR) was 15% for Cabometyx vs 0% for placebo in the PTC subgroup and 8% vs 0% in the FTC subgroup.^3 Another analysis will be presented related to outcomes for prespecified subgroups who received prior lenvatinib and/or sorafenib treatment. The data from this analysis showed Cabometyx maintained its PFS vs placebo irrespective of prior lenvatinib and/or sorafenib treatment.^4 Median PFS across the different groups included 16.6 months for Cabometyx vs 3.2 months for placebo in prior sorafenib (no lenvatinib) (HR 0.13, 95% CI 0.06–0.26), 5.8 months vs 1.9 months in prior lenvatinib (no sorafenib) (HR 0.28, 95% CI 0.16-0.48), and 7.6 months vs 1.9 months in prior sorafenib and lenvatinib (HR 0.27, 95% CI 0.13–0.54).^4 The safety profile identified in COSMIC-021, CheckMate -9ER and COSMIC-311 was consistent with that previously observed for Cabometyx in monotherapy and in combination. Ipsen thanks the patients and investigators involved in the COSMIC-021, CheckMate -9ER and COSMIC-311 clinical trials. Highlights: Ipsen: ASCO 2022: New Cabometyx® Data Show Encouraging Results in Monotherapy and in Combination Across Different Tumor Types Including Metastatic Non-Small Cell Lung Cancer. COSMIC-021 Phase Ib study is evaluating Cabometyx^® (cabozantinib) in combination with atezolizumab in advanced solid tumors, including non-small cell lung cancer. New analyses from pivotal Phase III Checkmate -9ER trial further support the superior efficacy of Cabometyx and nivolumab over sunitinib in advanced renal cell carcinoma. Two new analyses from pivotal Phase III COSMIC-311 trial further support the potential of Cabometyx in radioactive iodine-refractory differentiated thyroid cancer.