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
Ipsen (Euronext: IPN; ADR: IPSEY) has announced promising data on Cabometyx® (cabozantinib) to be presented at ASCO 2022, highlighting its efficacy across several cancer types including non-small cell lung cancer (NSCLC) and advanced renal cell carcinoma. The Phase Ib COSMIC-021 study showcases Cabometyx's potential in metastatic NSCLC when combined with atezolizumab. Results from the Phase III COSMIC-311 trial further affirm Cabometyx's effectiveness in treating radioactive iodine-refractory differentiated thyroid cancer. Overall, these findings underscore Cabometyx’s role as a significant treatment option.
- Encouraging data from Phase Ib COSMIC-021 trial in metastatic NSCLC showing manageable toxicity.
- Phase III COSMIC-311 trial indicates Cabometyx maintains superior efficacy in thyroid cancer compared to placebo.
- Median progression-free survival of 9.2 months (papillary) and 11.2 months (follicular) for Cabometyx vs much lower for placebo.
- None.
- 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
Disclaimer: Intended for international media and investor audiences only
Ipsen (Euronext: IPN; ADR: IPSEY) today 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
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.
“Currently, 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
“The 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,” said Dr.
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
Another analysis will be presented related to outcomes for prespecified subgroups
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.
ENDS
More information can be found during the presentation sessions outlined below:
Lead author |
Indication |
Abstract title |
Presentation number/timing (CDT) |
Neal |
NSCLC |
Cabozantinib (C) Plus Atezolizumab (A) or C Alone in Patients (Pts) With Advanced Non-Small Cell
|
Oral
Abstract 9005
|
Suárez |
RCC |
Association between depth of response and clinical outcomes: exploratory analysis in patients with previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 9ER
|
Oral
Abstract 4501
GU Cancer - Kidney and Bladder |
Pal |
Urothelial Carcinoma |
Cabozantinib (C) in Combination With Atezolizumab (A) in Urothelial Carcinoma (UC): Results From Cohorts 3, 4, 5 of the COSMIC-021 Study5 |
Oral Abstract 4504 Fri 3 Jun
GU Cancer - Kidney and Bladder |
Capdevila |
RAI-R DTC |
Cabozantinib versus placebo in patients (pts) with radioiodine-refractory (RAIR) differentiated thyroid cancer (DTC)
|
Poster Abstract 6081
Head & Neck Cancer |
Hernando |
RAI-R DTC |
Cabozantinib (C) versus placebo (P) in patients (pts) with radioiodine-refractory (RAIR) differentiated thyroid cancer (DTC)
|
Poster Abstract 6083
Head & Neck Cancer |
About non-small cell lung cancer (NSCLC)
Lung cancer is one of the leading causes of cancer death globally.6 There are broadly two different groups of lung cancer - NSCLC and SCLC (small cell lung cancer). NSCLC accounts for around 80
About renal cell carcinoma (RCC)
There were over 430,000 new cases of kidney cancer diagnosed worldwide in 2020.8 Of these, RCC is the most common type of kidney cancer, accounting for approximately
About radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC)
In 2020, over 580,000 new cases of thyroid cancer were diagnosed worldwide.13 Thyroid cancer is the ninth most commonly occurring cancer globally and incidence is three times higher in women than in men, with the disease representing one in every 20 cancers diagnosed among women.13 While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid cancer (DTC) makes up about 90 to
About the COSMIC-021 trial18
COSMIC-021 is a multicenter, Phase Ib, open-label study that was divided into two parts: a dose-escalation phase and an expansion cohort phase. In the expansion phase, the trial enrolled 23 cohorts in 12 tumor types: NSCLC, RCC, UC, castration-resistant prostate cancer, hepatocellular carcinoma, triple-negative breast cancer, epithelial ovarian cancer, endometrial cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, head and neck cancer, and DTC. Exelixis is the study sponsor of COSMIC-021. Both
About the CheckMate -9ER trial19
CheckMate -9ER was an open-label, randomized, multi-national Phase III trial evaluating people living with previously untreated advanced or metastatic RCC. A total of 651 patients (
About the COSMIC-311 trial20
COSMIC-311 was a multicenter, randomized, double-blind, placebo-controlled Phase III trial that enrolled 258 patients at 164 sites globally. Patients were randomized in a 2:1 ratio to receive either Cabometyx 60 mg or placebo once-daily. The primary endpoints were progression-free survival in the intention-to-treat population as well as objective response rate in the first 100 randomly assigned patients (objective response rate intention-to-treat [OITT] population), both evaluated by a blinded independent radiology committee. Additional endpoints included safety, overall survival and quality of life. Exelixis is the sponsor, and Ipsen is co-funding the COSMIC-311 trial.
About Cabometyx (cabozantinib)
Outside
The detailed recommendations for the use of Cabometyx are described in the Summary of Product Characteristics (EU SmPC)* and in the
Ipsen has exclusive rights for the commercialization of Cabometyx outside the
*This SmPC does not include details of the approval of Cabometyx on
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience. With Specialty Care sales of
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References
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1 Cabozantinib (C) Plus Atezolizumab (A) in Patients (Pts) With Advanced Non-Small Cell
2 Association between depth of response and clinical outcomes: exploratory analysis in patients with previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 9ER
3 Cabozantinib versus placebo in patients (pts) with radioiodine-refractory (RAIR) differentiated thyroid cancer (DTC)
4 Cabozantinib (C) versus placebo (P) in patients (pts) with radioiodine-refractory (RAIR) differentiated thyroid cancer (DTC)
5 Cabozantinib (C) in Combination With Atezolizumab (A) in Urothelial Carcinoma (UC): Results From Cohorts 3, 4, 5 of the COSMIC-021 Study
6
7
8 Kidney Cancer Factsheet. GLOBOCAN 2020. Accessed:
9 Kidney Cancer.
10 Infographic: Kidney Cancer.
11 Survival rates for kidney cancer.
12 Orlin, I et al., Renal cell carcinomas epidemiology in the era of widespread imaging.
13 Sung. H et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal For Clinicians. doi: 10.3322/caac.21660..
14 Cancer.Net. ASCO. Thyroid Cancer: Introduction. Last accessed:
15 Chen D. et al. Innovative analysis of distant metastasis in differentiated thyroid cancer. Oncol Lett 19: 1985- 1992, 2020. doi: 10.3892/ol.2020.11304
16 Worden F. Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer. Ther Adv Med Oncol. 6:267–279. doi: 10.1177/1758834014548188.
17 Fugazzola L. et al. 2019 European Thyroid Association Guidelines for the Treatment and Follow-Up of Advanced Radioiodine-Refractory Thyroid Cancer. Eur Thyroid J. 2019;8:227–245. doi: 10.1159/000502229.
18 ClinicalTrials.gov. Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03170960).
19 ClinicalTrials.gov. A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER) (NCT03141177).
20 ClinicalTrials.gov. A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer
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FAQ
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