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Novartis unveils new data at ESMO 2021
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Novartis unveils new data at ESMO 2021
Today Novartis announced innovative new key data in advanced breast and prostate cancer at the European Society for Medical Oncology (ESMO) Annual Meeting from its portfolio of approved and investigational therapies aimed at transforming the lives of people living with cancer.To get more novartis updates, you can visit shine news official website.
The results, presented today as one of the late-breaking studies, highlights the final overall survival (OS) analysis of the Phase III MONALEESA-2 study, which evaluated Kisqali® (ribociclib) in combination with letrozole compared to placebo plus letrozole in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with no prior systemic treatment for advanced disease.1
Ribociclib in combination with letrozole met its secondary endpoint of OS, demonstrating a statistically significant and clinically meaningful improvement in survival (median 63.9 vs. 51.4 months; HR=0.76; 95% CI: 0.63-0.93; p=0.004).1The analysis found that after a median follow-up of over six and a half years, the longest for any CDK4/6 inhibitor trial to date,4 the improvement in the median OS was over one year.1 MONALEESA-2 showed that after five years, patients treated with ribociclib in combination with letrozole had more than a 50% chance of survival (52.3% vs. 43.9%; 95% CI: 46.5-57.7 vs. 38.3-49.4).1 In MONALEESA-2, an exploratory analysis showed nearly a 12-month delay in time to chemotherapy with ribociclib and letrozole (median 50.6 vs. 38.9 months; HR=0.74; 95% CI: 0.61-0.91) compared to those taking letrozole alone.1 With this longer follow-up, no new safety signals were observed; adverse events were consistent with previously reported Phase III trial results for ribociclib.
At the time of the second interim analysis, in MONALEESA-2, the primary endpoint progression-free survival (PFS) was met at the initial analysis 25.3 months [median PFS; 95% CI (23.0–30.3) vs. 16.0 months (95% CI 13.4–18.2) for placebo plus letrozole; (HR=0.568; 95% CI 0.457-0.704; p<0.0001).6 These new OS results mark the third statistically significant and clinically meaningful survival benefit achieved by ribociclib in combination with endocrine therapy* in the MONALEESA programme. In the UK, breast cancer is the most common type of cancer, with around 55,000 women diagnosed with breast cancer each year.7,8 Approximately 30% of women with earlier stages of breast cancer will develop advanced disease.9 Advanced breast cancer is an incurable disease, it is known that only 66% of women will survive for over a year or more and around 26.2% for five years when diagnosed at the latest stage.10,11 Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland states, “We are very aware of the challenges faced by those living with advanced breast cancer and are reimagining how we deliver care in the UK. The innovative data show how by using our four-platform strategy we are securing meaningful advancements for patients with this disease. We know data saves lives and the deeper analysis of the statistically significant overall survival data for Kisqali is promising. It not only demonstrates our bold patient-first approach and ongoing commitment to the breast cancer community, but continued alignment to the priorities for the NHS in its Long-Term Plan for cancer patients. We continue to partner with the NHS and the entire health ecosystem to identify and implement solutions for these patients, no matter where they are or what their background.” Another key highlight of the data presented at ESMO is the quality-of-life data for the Phase III VISION study evaluating 177Lu-PSMA-617, an investigational targeted radioligand therapy for heavily pre-treated patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) plus standard of care for mCRPC versus standard of care alone. These data show delay in worsening of health-related quality of life (HRQoL) and pain in heavily pre-treated patients with PSMA-positive mCRPC compared to standard of care alone.5 Alessandra Dorigo, General Manager UK, Ireland, Baltics and Nordics in Novartis Advanced Accelerator Applications (AAA) comments, “Quality of life is one of the most important measures to look at in advanced prostate cancer. Many patients living with metastatic castration-resistant prostate cancer (mCRPC) experience reduced physical functioning as well as significant pain. The data from the Phase III VISION study of a radioligand therapy in this advanced prostate cancer setting confirm the potential of 177Lu-PSMA-617 to support better quality of life outcomes for people living with mCRPC. I believe we are driving forward genuine advances in prostate cancer where we know there is a great need for innovative treatment options that do not detrimentally impact a patients’ quality of life. We have a bold ambition to improve patient outcomes and are very excited about what we can achieve for these patients in the UK and beyond.”