{"id":28061,"date":"2022-05-27T09:00:00","date_gmt":"2022-05-27T07:00:00","guid":{"rendered":"https:\/\/d36deud6t4mnhi.cloudfront.net\/press-releases\/asco-2022-new-cabometyx-data-show-encouraging-results-in-monotherapy-and-in-combination-across-different-tumor-types-including-metastatic-non-small-cell-lung-cancer\/"},"modified":"2024-07-22T12:53:14","modified_gmt":"2024-07-22T10:53:14","slug":"asco-2022-new-cabometyx-data-show-encouraging-results-in-monotherapy-and-in-combination-across-different-tumor-types-including-metastatic-non-small-cell-lung-cancer","status":"publish","type":"press_release","link":"https:\/\/www.ipsen.com\/press-releases\/asco-2022-new-cabometyx-data-show-encouraging-results-in-monotherapy-and-in-combination-across-different-tumor-types-including-metastatic-non-small-cell-lung-cancer\/","title":{"rendered":"ASCO 2022: New Cabometyx\u00ae data show encouraging results in monotherapy and in combination across different tumor types including metastatic non-small cell lung cancer"},"content":{"rendered":"\n
PARIS, FRANCE,<\/strong> 26 May 2022 \u2013 Ipsen (Euronext: IPN; ADR: IPSEY) today announced encouraging data to be presented for the multi-targeted tyrosine kinase inhibitor (TKI), Cabometyx\u00ae <\/sup>(cabozantinib), across a range of cancer types at this year\u2019s 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.<\/p>\n\n\n\n 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).[i]<\/strong><\/a> 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.<\/p>\n\n\n\n \u201cCurrently, first-line immunotherapy with or without chemotherapy is the standard of care for patients with metastatic NSCLC but there is a real need for additional effective treatment options for those patients who progress after a prior immunotherapy,\u201d said Santiago Ponce-Aix, M.D., Head of Drug Development Department, Institute Gustave Roussy, France, and an investigator in the COSMIC-021 trial. \u201cThese new data are encouraging as they show the potential role of Cabometyx in creating an environment which may enhance atezolizumab\u2019s activity in NSCLC. We look forward to further data evaluating this combination for this patient population where there remains such a high unmet medical need.\u201d<\/p>\n\n\n\n \u201cThe therapeutic potential of Cabometyx as a treatment option against a broad range of tumors including NSCLC is continuing to be evaluated and these data demonstrate our ambition to bring meaningful new treatments to patients. These latest data support the potential role of Cabometyx to positively impact treatment when paired with immunotherapy, and we will continue to evaluate Cabometyx as both a monotherapy and in combination with other innovative therapies for the most difficult-to-treat cancers,\u201d said Dr. Howard Mayer, Executive Vice President and Head of Research and Development at Ipsen.<\/p>\n\n\n\n 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.[ii]<\/strong><\/sup><\/a> 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<\/sup><\/p>\n\n\n\n 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.[iii]<\/strong><\/a> 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<\/sup><\/p>\n\n\n\n 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.[iv]<\/strong><\/sup><\/a> 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\u20130.26), 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\u20130.54).4<\/sup><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Ipsen thanks the patients and investigators involved in the COSMIC-021, CheckMate -9ER and COSMIC-311 clinical trials.<\/p>\n\n\n\n ENDS<\/strong><\/p>\n\n\n\n More information can be found during the presentation sessions outlined below:<\/p>\n\n\n\n