Novartis medverkan på ASCO i sammandrag

Novartis medverkan på ASCO i sammandrag
En av höjdpunkterna på kongressen, som i år hålls för 52 gången, 3-7 juni i Chicago, är resultat från olika studier på kombinationsbehandlingen Tafinlar(dabrafenib)/Mekinist(trametinib). Kombinationen dabrafenib/trametinib är sedan september 2015 godkänd inom EU för behandling av metastaserat BRAF V600-positivt melanom och i samband med årets ASCO släpps data för långtidsbehandling.

Dessutom presenteras fas II-data från en studie där dabrafenib/trametinib prövats mot BRAFV600E-positiv, icke småcellig lungcancer, NSCLC.

  • Genomic analysis and 3-y efficacy and safety update of COMBI-d: A Phase III study of dabrafenib (D) + trametinib (T) vs D monotherapy in patients with unresectable or metastatic BRAF V600E/K-mutant cutaneous melanoma[Abstract #9502; Monday, June 6, 1:39 PM CDT]
  • An open-label Phase II trial of dabrafenib (D) in combination with trametinib (T) in patients with previously treated BRAF V600E–mutant advanced non-small cell lung cancer (NSCLC; BRF113928)[Abstract #107; Monday, June 6, 9:57 AM CDT]
  • ROAR: A Phase II, open-label study in patients with BRAF V600E–mutated rare cancers to investigate the efficacy and safety of dabrafenib (D) and trametinib (T) combination therapy[Abstract # TPS2604; Sunday, June 5, 8:00 AM CDT]

Novartis fortsätter att forska och utveckla behandlingar inom många områden där de medicinska behoven är stora. På årets upplaga av ASCO kommer företaget bland annat att presentera resultat från studier inom indikationerna myelofibros och avancerad cMET+ icke småcellig lungcancer NSCLC.

  • Long-term outcomes of ruxolitinib (RUX) therapy in patients with myelofibrosis (MF): 5-year update from COMFORT-I[Abstract #7012; Monday, June 6, 11:30 AM CDT]**
  • Phase I study of the safety and efficacy of the cMET inhibitor capmatinib (INC280) in patients (pts) with advanced cMET+ non-small cell lung cancer (NSCLC)[Abstract #9067; Saturday, June 4, 8:00 AM CDT]

Dessutom presenteras data kring effekt och säkerhet för flera av Novartis etablerade läkemedel, som Zykadia (ceritinib) och Afinitor (everolimus) samt data på substanser och immunoterapier som ingår i kliniska prövningsprogram inom olika terapiområden, som exempelvis ribociclib mot bröstcancer, capmatinib mot icke småcellig lungcancer och PD1-hämmaren PDR001 mot olika solida tumörer.

Bröstcancer

Inom bröstcancer presenteras data från flera olika kliniska studier, bland annat på everolimus och ribociclib.

  • A randomized trial (MA.17R) of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer[Abstract #LBA1; Sunday, June 5, 1:40 PM CDT]
  • Patient-reported outcomes from MA.17R: A randomized trial of extending adjuvant letrozole for 5 years after completing an initial 5 years of aromatase inhibitor therapy alone or preceded by tamoxifen in postmenopausal women with early-stage breast cancer[Abstract #LBA506; Monday, June 6, 3:15 PM CDT]
  • Correlation of PIK3CA mutations in cell-free DNA (cfDNA) and efficacy of everolimus (EVE) in metastatic breast cancer: Results from BOLERO-2[Abstract #519; Sunday, June 5, 11:30 AM CDT]
  • Prevention of everolimus/exemestane (EVE/EXE) stomatitis in postmenopausal (PM) women with hormone receptor-positive (HR+) metastatic breast cancer (MBC) using a dexamethasone-based mouthwash (MW): Results of the SWISH trial[Abstract #525; Sunday, June 5, 8:00 AM CDT]
  • Evaluation of lapatinib as a component of neoadjuvant therapy for HER2+ operable breast cancer: 5-year outcomes of NSABP protocol B-41[Abstract #501; Monday, June 6, 1:27 PM CDT]
  • Ribociclib (LEE011) and letrozole in estrogen receptor-positive (ER+), HER2-negative (HER2-) advanced breast cancer (aBC): Phase Ib safety, preliminary efficacy and molecular analysis[Abstract #568; Sunday, June 5, 8:00 AM CDT]

Lungcancer

Inom icke småcellig lungcancer presenterar Novartis data från studier på bland annat ceritinib och kombinationsbehandlingen capmatinib/gefitinib.

  • Genetic landscape of ALK+ non-small cell lung cancer (NSCLC) patients and response to ceritinib in ASCEND-1[Abstract #9064; Saturday, June 4, 8:00 AM CDT]
  • Phase II safety and efficacy results of a single-arm Ph Ib/II study of capmatinib (INC280) + gefitinib in patients with EGFR-mutated (mut), cMET-positive (cMET+) non-small cell lung cancer (NSCLC)[Abstract #9020; Saturday, June 4, 3:00 PM CDT]

Resultat från prövningar inom andra onkologiområden

Novartis släpper också spännande data från tidig klinisk fas, däribland PD-1-hämmaren PDR001 mot solida tumörer och buparlisib mot cancer inom head and neck.

  • A first-in-human phase I study of the anti-PD-1 antibody PDR001 in patients with advanced solid tumors[Abstract #3060; Sunday, June 5, 8:00 AM CDT]
  • BERIL-1: A Phase II, placebo-controlled study of buparlisib (BKM120) plus paclitaxel vs placebo plus paclitaxel in patients with platinum-pretreated recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)[Abstract #6008; Sunday, June 5, 10:12 AM CDT]
  • BERIL-1: Biomarker results from targeted sequencing of circulating tumor DNA (ctDNA) and archival tissue in a randomized Phase II study of buparlisib (BKM120) or placebo + paclitaxel in patients with head and neck squamous cell carcinoma (HNSCC) [Abstract #6045; Saturday, June 4, 1:00 PM CDT]
  • A Phase II study of the efficacy and safety of the cMET inhibitor capmatinib (INC280) in patients (pts) with advanced hepatocellular carcinoma (HCC)[Abstract #4074; Saturday, June 4, 8:00 AM CDT]
  • Everolimus (EVE) in advanced, nonfunctional, well-differentiated neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin: Second interim overall survival (OS) results from the RADIANT-4 study[Abstract #4090; Saturday, June 4, 8:00 AM CDT]
  • Genomic mutation profiling (GMP) and clinical outcome in patients (pts) treated with ribociclib (CDK4/6 inhibitor) in the Signature program[Abstract 2528; Sunday, June 5, 8:00 AM CDT]