Αρχική World News The Combination of Nivolumab and Cabozantinib Provides a New First-Line Treatment Option...

The Combination of Nivolumab and Cabozantinib Provides a New First-Line Treatment Option in Advanced Clear Cell RCC

Efficacy data with nivolumab plus cabozantinib showing improved survival and response rates, together with an acceptable safety profile presented by Prof. Toni K. Choueiri of the Dana-Farber Cancer Institute and The Lank Centre for Genitourinary Oncology in Boston, USA at ESMO Virtual Congress 2020, support this combination as a first-line treatment option for patients with advanced clear cell renal cell carcinoma (RCC).

Prof. Choueiri presented first results from the phase III CheckMate 9ER study evaluating nivolumab plus cabozantinib compared with sunitinib as first-line treatment of advanced clear cell RCC. This study was prompted by reports that both nivolumab, a checkpoint inhibitor and cabozantinib, a tyrosine kinase inhibitor (TKI) administered as monotherapies demonstrated efficacy and a manageable safety profile in advanced RCC. Prof. Choueiri and colleagues reasoned that the immunomodulatory properties of cabozantinib may counteract tumour-induced immunosuppression.

In CheckMate 9ER patients were stratified by IMDC risk score, tumour PD-L1 expression, as well as region and randomised 1:1 to receive a 240 mg flat dose of i.v. nivolumab every 2 weeks plus oral cabozantinib at 40 mg once daily or oral sunitinib at 50 mg for 4 weeks in 6-week cycles until disease progression or unacceptable toxicity occurred for a maximum treatment duration of two years.

Progression-free survival (PFS; α = 0.05 final) by blinded independent central review (BICR) served as the primary endpoint and secondary endpoints (hierarchical testing) included overall survival (OS; α = 0.011 at the first interim analysis), objective response rate (ORR; α = 0.05 at the final analysis) by BICR, and safety.

Of the 651 patients randomised, 22.6% had favourable risk, 57.6% intermediate risk, and 19.7% of patients had poor risk and PD-L1 expression was ≥1% in 24.9% of patients.  A total of 323 patients were treated with the nivolumab plus cabozantinib combination and 328 patients received sunitinib.

Nivolumab plus cabozantinib significantly improved survival over sunitinib

With median follow-up of 18.1 months and a minimum of 10.6 months, the study met all efficacy endpoints.

The combination treatment doubled PFS over sunitinib; median PFS was 16.6 months compared to 8.3 months (hazard ratio [HR] 0.51; 95% confidence interval [CI] 0.41–0.64], p < 0.0001).

The OS was also significantly improved with nivolumab plus cabozantinib versus sunitinib, median OS was not reached (HR 0.60; 98.89% CI 0.40–0.89; p = 0.0010).

The ORR was significantly higher at 55.7% (95% CI 50.1–61.2) with the combination versus 27.1% (95% CI 22.4–32.3) with sunitinib (p < 0.0001); the median duration of response was 20.2 versus 11.5 months, respectively. With nivolumab plus cabozantinib 8.0% of patients achieved complete response compared with 4.6% of sunitinib patients.

These favourable results were consistent across prespecified IMDC risk and PD-L1 subgroups.

Any-grade treatment-related adverse events (TRAEs) occurred in 96.6% of patients receiving the combination compared with 93.1% of patients on sunitinib and grade ≥3 TRAEs were reported in 60.6% versus 50.9% of patients, respectively. 

TRAEs led to discontinuation of nivolumab in 5.6% of patients, and of cabozantinib in 6.6% of patients whereas 3.1% of patients discontinued the combination (total 15.3%) and 8.8% of patients discontinued sunitinib.

One treatment-related death occurred with nivolumab plus cabozantinib and two occurred with sunitinib. 

Health-related Quality-of-life also favoured the combination treatment.

Conclusions

Based on these favourable results, the authors concluded that nivolumab plus cabozantinib demonstrated PFS, OS and ORR that were superior to sunitinib in the first-line treatment for advanced clear cell RCC.

Taken together with a safety profile for the combination that was manageable and consistent with the known single-agent adverse event profiles of nivolumab and cabozantinib, these efficacy results support nivolumab cabozantinib as a new checkpoint inhibitor plus TKI option for patients with advanced clear cell RCC.

Funding for this study was reported from Bristol-Myers Squibb Company (Princeton, NJ), ONO Pharmaceutical Company Ltd. (Osaka, Japan), and Exelixis Inc. (Alameda, CA).

Reference

696O_PR – Choueiri TK, Powles T, Burotto M, et al. Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial. ESMO Virtual Congress 2020.

Source

NEWSLETTER

Συμπληρώστε το email σας για να λαμβάνετε τις σημαντικότερες ειδήσεις από το ogkologos.com

Βρείτε μας

2,449ΥποστηρικτέςΚάντε Like
57ΑκόλουθοιΑκολουθήστε

Διαβαστε Επίσης

Καρκίνος και Κορωνοϊός (COVID-19) ΜΕΡΟΣ Α

Εάν είστε καρκινοπαθής, το ανοσοποιητικό σας σύστημα μπορεί να μην είναι τόσο ισχυρό όσο κανονικά, έτσι μπορεί να ανησυχείτε για τους κινδύνους που σχετίζονται...

ΠΑΓΚΟΣΜΙΑ ΗΜΕΡΑ ΚΑΡΚΙΝΟΥ

Η Παγκόσμια Ημέρα Κατά του Καρκίνου καθιερώθηκε με πρωτοβουλία της Διεθνούς Ένωσης κατά του Καρκίνου (UICC), που εκπροσωπεί 800 οργανώσεις σε 155 χώρες του...

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ)

ΕΞΕΛΙΞΕΙΣ ΣΤΗ ΘΕΡΑΠΕΙΑ ΤΟΥ ΜΗ-ΜΙΚΡΟΚΥΤΤΑΡΙΚΟΥ ΚΑΡΚΙΝΟΥ ΤΟΥ ΠΝΕΥΜΟΝΑ (ΜΜΚΠ) Γράφει ο Δρ Παπαδούρης Σάββας, Παθόλογος-Ογκολόγος   Ο ΜΜΚΠ βρίσκεται αναλογικά στο 80% και πλέον του συνολικού...

Διατρέχουν όντως οι καρκινοπαθείς μεγαλύτερο κίνδυνο λόγω κοροναϊού;

Σε πρακτικό επίπεδο, τα δεδομένα των σχετικών μελετών υποδηλώνουν ότι η χημειοθεραπεία ή οι άλλες αντι-νεοπλασματικές θεραπείες δεν αυξάνουν σημαντικά τον κίνδυνο θνησιμότητας από...

FDA: Η ακτινοβολία των smartphones δεν προκαλεί καρκίνο

Σε μια νέα έκθεσή της, η Υπηρεσία Τροφίμων και Φαρμάκων (FDA) των ΗΠΑ αναφέρει ότι επανεξέτασε τις σχετικές επιστημονικές έρευνες που δημοσιεύθηκαν τα τελευταία...

Νέα ανακάλυψη, νέα ελπίδα για τον καρκίνο

Ένα νεοανακαλυφθέν τμήμα του ανοσοποιητικού μας συστήματος θα μπορούσε να αξιοποιηθεί για την αντιμετώπιση όλων των ειδών καρκίνου, σύμφωνα με επιστήμονες του πανεπιστημίου Cardiff...
- Advertisment -

Ροή Ειδήσεων

Overall Breast Cancer Incidence Down Since 1999, Rates Increase for Women Under 40

U.S. breast cancer death rates decreased by about 1% per year between 2013 and 2018. What were the new case rates during that same...

Impressive Responses to PD-1 Blockade in a Large Cohort of Children and Young Adults with Recurrent/Progressive Germline DNA Replication Repair-Deficient Cancers

A large, observational, registry-based study that leveraged systematically collected data gathered both retrospectively and prospectively through the International Replication Repair Deficiency Consortium reveals impressive...

2-Year-Boy Is So Excited To See Himself In Disney’s ‘Encanto’

The importance of representation in media has been a growing topic of concern, and companies have responded by adding more diversity to their characters,...

Man Walks Entire Continent To Spread Awareness About Mental Health & Suicide Prevention

Matthew Fennell is walking over 3,000 miles across Australia for an important cause and one that is near and dear to his heart. Last year,...

Boy Battling Cancer Becomes Honorary Police Officer, Sworn In To 45 Agencies

At just ten years old, Devarjaye “DJ” Daniel has already been through more than most people go through in their entire lives. DJ has been...

Paclitaxel and Carboplatin Not Inferior When Compared with Paclitaxel and Ifosfamide for the Treatment of Patients with Uterine Carcinosarcoma

With regard to overall survival (OS), paclitaxel and carboplatin was not inferior and demonstrated improved progression-free survival (PFS) when compared with paclitaxel and ifosfamide...