Benzinga | Aug 30, 2021 04:54AM EDT

Novartis Announced Data Supporting Upcoming Regulatory Filings for Tislelizumab in People With Squamous and Non-squamous Non-small Cell Lung Cancer, and for Alpelisib in People With PIK3CA-related Overgrowth Spectrum at ESMO

Novartis (NYSE:NVS) will present new data from its robust portfolio and pipeline of advanced therapeutic platforms in solid tumors, with more than 55 abstracts from Novartis-sponsored and investigator-initiated trials accepted at the upcoming European Society for Medical Oncology (ESMO) Congress 2021. The ESMO Congress will be held virtually September 16-21, 2021.

"At Novartis, we boldly push science further to make a meaningful difference to patients," said Susanne Schaffert, PhD, President, Novartis Oncology. "With deeper analyses in overall survival and quality of life in breast and prostate cancer, as well as exciting research in other solid tumors, our data at ESMO demonstrates our ambition to transform lives and renew patients' hope for the future."

Key abstracts accepted by ESMO include:

Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2) advanced breast cancer (ABC) treated with endocrine therapy (ET) ribociclib [Kisqali(r) (ribociclib)*; Late-breaker abstract presentation # LBA17; Proffered paper session: Sunday, Sept. 19, 2:10 PM CEST]

Association of quality of life (QoL) with OS in patients with HR+/HER2 ABC treated with ribociblib + ET in the ML-3 ML-7 trials [Kisqali; Abstract presentation # 233P; poster available: Monday, Sept. 13, 12:05 AM CEST]

Health-related QoL, pain and safety outcomes in the phase 3 VISION study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPR) [Abstract presentation # 576MO; mini oral presentation: Sunday, Sept. 19, 5:50 PM CEST]

EPIK-P1: Retrospective chart review study of patients with PIK3CA-related overgrowth spectrum (PROS) who have received alpelisib as part of a compassionate use programme [Late-breaker abstract presentation # LBA23; Proffered paper session: Friday, Sept. 17, 1:30 PM CEST]

RATIONALE 304: Tislelizumab plus chemotherapy (chemo) vs chemo alone as first-line (1L) treatment for non-squamous (non-sq) non-small cell lung cancer (NSCLC) in patients who are smokers vs non-smokers [Abstract presentation # 1290P; poster available: Monday, Sept. 13, 12:05 AM CEST]

RATIONALE 307: Tislelizumab plus chemo vs chemo alone as 1L treatment for advanced sqNSCLC in patients who were smokers vs non-smokers [Abstract presentation # 1297P; poster available: Monday, Sept. 13, 12:05 AM CEST]Additional data presentationshighlight the breadth of our pipeline and our ongoing commitment to discover and develop innovations that address unmet medical needs for patients with cancer:

Medicine Abstract Title Abstract NumberProstate Cancer177Lu-PSMA-617 PSMAddition: a phase 3 trial to compare treatment with 177Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in patients with metastatic hormone-sensitive prostate cancer Abstract presentation # 647TiPPoster available: Thursday, Sept. 16, 08:30 AM CEST177Lu-PSMA-617 PSMAfore: a phase 3 study to compare 177Lu-PSMA-617 treatment with a change in androgen receptor pathway inhibitor in taxane-nave patients with mCRPC Abstract presentation #648TiPPoster available: Thursday, Sept. 16, 08:30 AM CEST

Breast Cancer Piqray(r) (alpelisib) Antineoplastic therapies after alpelisib or placebo + fulvestrant in patients with HR+/HER2-, PIK3CA-mutated ABC: an analysis from SOLAR-1 Abstract presentation # 309PPoster available: Monday, Sept. 13, 12:05 AM CEST

Neuroendocrine Tumors (NET)Lutathera(r) (lutetium Lu 177 dotatate)** The phase 3 NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: further survival analyses Abstract presentation # 1102PPoster available: Friday, Sept. 17, 09:00 AM CESTLutathera A phase II trial to evaluate the safety and dosimetry of 177Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, pheochromocytomas and paragangliomas Abstract presentation # 1122TiPPoster available: Friday, Sept. 17, 09:00 AM CESTWith the unique opportunity to engage a variety of cancer care stakeholders in Europe, Novartis will also host an ESMO Industry Connect virtual panel on Monday, September 20, 8:00 AM CEST, under the #EUnite initiative, to discuss opportunities presented by the European Commission 'Europe's Beating Cancer Plan,' and practical steps to address inequalities in cancer care in the region. Featured panelists include:

Bettina Ryll Board Member of the European Commission's Cancer Mission, Physician and Founder of Melanoma Patient Network EuropeFatima Cardoso Director Breast Unit, Champalimaud Clinical Centre; President, Advanced Breast Cancer Global AllianceJohn Ryan EU Commission, Deputy Director General for HealthMore information and access to the event will be available to all registered congress participants.

Additional details on Novartis-sponsored abstracts and activities, and access to the presentations will be available on https://www.hcp.novartis.com/virtual-congress/esmo-2021/, starting on September 16.