Onco Actu du 7 mai 2020

	1.1 BIOLOGIE - GÉNOME
Pediatric Cancer Patients With Solid Tumors Have Many Druggable Germline Alterations [Genome Web] The researchers analyzed the germline DNA of 1,507 C-AYA patients with solid tumors and found that 12 percent of these patients carried germline P/LP variants in KCPG genes.
	4.3 DÉP., DIAG. & PRONO. - INDUSTRIELS
Foundation Medicine Receives FDA Approval for FoundationOne®CDx as the Companion Diagnostic for Tabrecta™ (capmatinib), the Only FDA-Approved MET Inhibitor for Patients With Metastatic Non-Small Cell Lung Cancer With METex14 [Foundation Medicine] As part of the strategic collaboration with Novartis, which now includes two companion diagnostics for the Novartis portfolio of targeted oncology and immuno-oncology therapeutics, a companion diagnostic for Tabrecta is also in development for Foundation Medicine’s liquid biopsy assay.
	4.9 DÉP., DIAG. & PRONO. - SEIN
Breast cancer 'signature' predicts response to new drug class [Walter and Eliza Hall Institute] The research team discovered a ‘gene signature’ in human breast cancer samples that predicted whether they would be killed by Smac-mimetics including a drug called birinapant, which has entered phase 2 clinical trials for certain cancers.
	5.1 TRAITEMENTS - PRÉ-CLINIQUE
Killing 'sleeper cells' may enhance breast cancer therapy [Walter and Eliza Hall Institute] The research team showed that venetoclax could kill breast cancer cells that had been ‘put to sleep’ by a drug that blocks cell division (called a CDK4/6 inhibitor), which is currently used in combination with hormone therapies to treat ER+ breast cancer.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
FDA delays decision on approval of Bristol Myers' CAR-T [Fierce Biotech] Bristol Myers filed for FDA approval after linking liso-cel to a 53% complete response rate. The data suggested liso-cel can compete against Gilead’s Yescarta and Novartis’ Kymriah, but the original filing lacked some information the FDA wanted to see.
Another delay for Bristol Myers cell therapy as FDA extends review [Biopharma Dive] This isn't the first delay for liso-cel, which is under review to treat relapsed or refractory large B-cell lymphoma after prior treatments.
A risky bet on a long-delayed CAR-T drug now faces a do-or-die deadline — where any slip can kill a $9 CVR [EndPoints] That moves the goal line on a decision to November 16, just 6 weeks or so before the end-of-year deadline Bristol Myers established for Celgene investors as one of 3 positive marketing decisions that have to be won to get a $9 contingent value right, or CVR, payoff in their $74 billion merger.
Bristol Myers Squibb Provides Update on Biologics License Application (BLA) for Lisocabtagene Maraleucel (liso-cel) [BMS] Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy designed to target CD19, which is a surface glycoprotein expressed during normal B-cell development and maintained following malignant transformation of B cells.
U.S. FDA extends review of Bristol Myers' cancer therapy acquired in Celgene deal [Reuters] The company said it had submitted additional information on the therapy known as liso-cel, which was considered a major amendment to the marketing application by the agency, which would now announce its decision by Nov. 16 versus its earlier deadline of Aug. 17.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Novartis Drug Wins FDA Approval for Lung Cancers With Specific Mutation [Xconomy] Capmatinib was discovered by scientists at Incyte. The partnership initially paid Incyte $210 million. Milestones could bring the biotech up to $1.2 billion more.
Novartis lands capmatinib approval, giving them a second potential blockbuster from Incyte [EndPoints] The drug will cost $17,950 for a 28-day supply, which Novartis said was “comparable to the cost of other existing therapies prescribed for this aggressive form of lung cancer.”
Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14 [Novartis] Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type, and is expected to be available to patients in the coming days.
FDA approves Novartis drug for a hard-to-treat type of lung cancer [Reuters] Drugmakers like Novartis are increasingly using biomarker-driven drugs to treat patients with rare tumors - only about 3%-4% of lung cancer patients have the MET exon14 skipping mutation - that have proven very difficult for oncologists to fight with their existing arsenal of medicines.
FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer [FDA] Tabrecta (capmatinib) is the first FDA-approved therapy to treat NSCLC with specific mutations (those that lead to mesenchymal-epithelial transition or MET exon 14 skipping).
	5.5 ASCO
New data at the ASCO20 Virtual Scientific Program reflects Roche’s commitment to accelerating progress in cancer care [Roche] First clinical data from tiragolumab, Roche’s novel anti-TIGIT cancer immunotherapy, in combination with Tecentriq® (atezolizumab) in patients with PD-L1-positive metastatic non-small cell lung cancer (NSCLC).
	5.9.5 AACR - CAR-T, THÉRAPIES CELLULAIRES
Encouraging Signals for New Cancer Cell Therapy Strategies [Xconomy] Strategies that may improve upon first-generation therapies were presented during the American Association for Cancer Research virtual meeting with encouraging early activity, but these treatments also have hurdles to overcome.