Novartis unveils strong presence at ASCO Congress, including overall survival data in prostate and breast cancer

Novartis continues to push the boundaries of innovation, reimagining medicine, with bold science as it today unveils strong presence at ASCO, including overall survival data in prostate and breast cancer

  • Compelling data demonstrate Novartis’ unwavering commitment to reimagining cancer care for patients in the UK with prostate cancer, advanced breast cancer, lung cancer, melanoma and neuroendocrine tumours
  • 177Lu-PSMA-617 significantly improves overall survival (OS) and radiographic progression-free survival (rPFS) for men with late stage advanced prostate cancer in Phase III VISION[i]
  • Kisqali® (ribociclib) in combination with fulvestrant reports longest median overall survival in CDK4/6 inhibitor trials for postmenopausal HR+/HER2- metastatic breast cancer patients from an exploratory analyses of the MONALEESA-3 trial[ii]
  • Lutathera® (lutetium (177Lu) oxodotreotide) final OS data from Phase III NETTER-1 study in adults with somatostatin receptor-positive midgut neuroendocrine tumours[iii]

Novartis has today announced encouraging new data at the American Society of Clinical Oncology (ASCO) Annual Meeting from its portfolio of approved and investigational therapies aimed at transforming the lives of people living with cancer. As the only pharmaceutical company pursuing a four-platform strategy that harnesses targeted therapies, radioligand therapy (RLT), cell and gene therapy, and immunotherapy, Novartis are on a relentless pursuit to secure the best outcomes for cancer patients in the UK.

“Our bold ambition is driven by our passion for patients and our mission to extend and improve the lives of those living with cancer and serious blood disorders, and ultimately find cures,” said Mari Scheiffele, Novartis Oncology General Manager, UK & Ireland. “These exciting data from across our four therapeutic platforms, notably the overall survival data in prostate and advanced breast cancer, illustrate how we are uniquely positioned to deliver transformative innovations that may bring renewed hope for UK patients.”

Key highlights of the data being presented at ASCO centre around the updated Phase III radioligand therapy study VISION, an investigational therapy for people living with with metastatic castration-resistant prostate cancer and around updated overall survival data for Kisqali (ribociclib) in combination with fulvestrant in the MONALEESA 3 trial. In the UK, around 55,000 women are diagnosed with breast cancer each year.[iv] 30% of women with earlier stages of breast cancer will develop advanced disease.[v] Yet worryingly, prostate cancer has overtaken breast cancer to become the third most common cause of cancer death in the UK after lung and colorectal cancer.[vi]

The Phase III VISION study is evaluating the efficacy and safety of 177Lu-PSMA-617, a targeted RLT plus best standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who had already been treated with taxane and androgen pathway inhibitors, compared to best standard of care alone. The trial met both primary endpoints with men who received 177Lu-PSMA-617 plus best standard of care achieving a 38% reduction in risk of death (median OS benefit of 4 months) and a 60% reduction in the risk of radiographic disease progression or death (median rPFS benefit of 5 months) compared to best standard of care alone1. Results from the VISION trial [Abstract #LBA4] will be presented at a plenary session at the congress on Sunday, 6 June at 18.00 BST (13:00 EDT) and included in an upcoming EU regulatory submission.

“Men with metastatic prostate cancer have about a 3 in 10 chance of surviving 5 years[vii] and need new treatment options. These data from the first Phase III study of a radioligand therapy in this advanced prostate cancer setting confirm the potential of 177Lu-PSMA-617 targeted therapy to improve clinical outcomes,” said Alessandra Dorigo, General Manager UK, Ireland, Baltics and Nordics in Novartis Advanced Accelerator Applications (AAA). “With more than 15 dedicated early to late development and research programmes underway, our comprehensive development programme will continue to explore targeted radioligand therapy, in prostate and across a number of tumour types.”

The Phase III MONALEESA-3 trial is analysing the efficacy and safety of treating postmenopausal women with HR+/HER2- advanced breast cancer (ABC) with fulvestrant +/- ribociclib.2 In this study the ribociclib arm demonstrated statistically significant longer median OS when compared with the placebo arm. The updated exploratory analysis of MONALEESA-3 trial presented at ASCO 2021 reported the longest OS benefit seen in a CDK4/6 inhibitor + fulvestrant in this population of women to date.2 Which adds further strength to the data. In this updated analysis, the need for chemotherapy was delayed by 4 years (48.1 months) in patients taking Kisqali in combination with fulvestrant and 28.8 months in the patients taking fulvestrant alone (HR=0.70; 95% CI: 0.57-0.88). Adverse events were consistent with previously reported Phase III trial results2

This data [Abstract #1001] was presented at a plenary session at the congress on Saturday, 5 June at 18.30 BST (13.30 EDT).

Novartis has over 30 years of heritage in oncology, spanning back to the approval of the first targeted therapy and beyond, transforming the lives of people living with cancer and life-threatening blood disorders. Novartis’ bold ambition is grounded in its industry-leading oncology and haematology pipeline of more than 45 different compounds across 70+ development programmes. The ongoing research potentially offers renewed hope for these patients who have limited or inadequate treatment options, as we reimagine medicine.