Onco Actu du 11 mai 2020

	4.12 BIOPSIES LIQUIDES
Blood test for cancer detection company Grail rakes in $390M in latest round [EndPoints] Just over a week after Third Rock-backed Thrive unveiled ‘real world’ data from a large study evaluating the ability of its blood test to sniff out early signs of cancer in individuals with no history of the disease, rival Grail has raised a gargantuan $390 million in its latest round of financing.
Prospective Study Adds Evidence for CellMax Life Liquid Biopsy Utility in CRC Screening [Genome Web] Investigators from the Veterans Affairs Palo Alto Healthcare System reported that CellMax's FirstSight test detected 100 percent of cancers, as well as 75.5 percent of advanced adenomas (a precancerous lesion typically removed during colonoscopies to prevent malignant progression) with 90 percent specificity for negative controls in a cohort of 354 individuals presenting for colonoscopy.
	5.12.11 IMMUNOTHÉRAPIES - PRÉ-CLINIQUE
More Selective Elimination of Leukemia Stem Cells and Blood Stem Cells [University of Zurich] A group of researchers led by the University of Zurich have now shown how human healthy and cancerous hematopoietic stem cells can be more selectively eliminated using immunotherapy instead of chemotherapy in mice.
	5.2 PHARMA
Enhertu granted Breakthrough Therapy Designation in the US for HER2-positive metastatic gastric cancer [AstraZeneca] AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.
	5.2.6 PHARMA - BIOTECH
Nanobiotix announces first phase I trial with NBTXR3 in pancreatic cancer is safe to proceed per US FDA [Nanobiotix] The trial is a phase I dose escalation study evaluating the safety and feasibility of NBTXR3 activated by radiation therapy in patients with locally advanced or borderline-resectable pancreatic ductal adenocarcinoma.
	5.3.4 TRAITEMENTS - AMM (FDA, EMA,...)
Novartis wins approval for niche lung cancer drug [Biopharma Dive] Tabrecta, formerly known as capmatinib, will likely square off against Merck KGaA's Tepmetko, which won Japanese approval in March and has a Breakthrough Therapy Designation from the FDA.
Approval of targeted therapies first line for prostate cancer ‘will ease COVID-19 pressures’ [Institute of Cancer Research] The Institute of Cancer Research (ICR) was also critical of NHS England for taking so long over its recommendation, and for limiting use of abiraterone only to patients who could not take enzalutamide.
Encorafenib, Cetuximab Combination Approved for Metastatic Colorectal Cancer [NCI] The approval covers the use of encorafenib in combination with cetuximab (Erbitux) in adults with metastatic colorectal cancer whose tumors have a specific mutation in the BRAF gene, called V600E, and who have already undergone at least one prior treatment regimen.
	5.3.4.1 TRAITEMENTS - AMM (FDA, EMA,...) - SELPERCATINIB
A groundbreaking cancer drug nabs fast OK, giving Eli Lilly boasting rights as a rival speeds close behind [EndPoints] The approval marks another win for advocates of rapid development, with the Loxo team jumping from their first treatment to an approval on Phase I/II data in 3 short years.
Lilly's Loxo buyout bears fruit as FDA clears cancer drug Retevmo [Biopharma Dive] Previously known as selpercatinib, Retevmo was the chief draw in Lilly's $8 billion acquisition of Loxo Oncology early last year.
FDA approves Eli Lilly drug for thyroid, lung cancers driven by a genetic mutation [Reuters] Lilly will price the drug to be sold under the brand name Retevmo at $20,600 for 30 days of treatment, said Anne White, head of Lilly’s oncology division.
Lilly Receives U.S. FDA Approval for Retevmo™ (selpercatinib), the First Therapy Specifically for Patients with Advanced RET-Driven Lung and Thyroid Cancers [Lilly] Accelerated approval based on data from LIBRETTO-001 Phase 1/2, largest trial ever reported in patients with RET-driven cancers.
FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion [FDA] Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.
Eli Lilly Gets Edge in the “RET” Race With FDA Nod for Cancer Drug [Xconomy] Selpercatinib, a capsule taken twice daily, is designed to block an enzyme that aids this tumor growth. But before a patient receives the Lilly drug, the RET gene alteration must be confirmed by a lab test. As of now, there is no FDA-approved companion diagnostic for detecting RET fusions or mutations.
	5.3.4.2 TRAITEMENTS - AMM (FDA, EMA,...) - OLAPARIB
LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer [Merck] Improved the Median Time to Disease Progression (37.2 months) vs. Bevacizumab Alone (17.7 months) Following Response to Platinum-Based Chemotherapy with Bevacizumab.
	5.4 TRAITEMENTS - ECONOMIE
NICE draft guidance recommends new treatment option for people with early breast cancer [Nice] NICE has published draft guidance which recommends trastuzumab emtansine (also called Kadcyla and made by Roche) as an option for some people with HER2-positive early breast cancer.
Roche's Kadcyla wins NICE backing in early breast cancer use [Fierce Pharma] Like all other drugmakers that secure NICE recommendations, Roche has offered a confidential discount off its average per-patient list price of £51,000 (about $63,100).
	5.5.1.1 ASCO (GÉNÉRAL) - INDUSTRIELS
Merck to Present New Data from its Broad Oncology Portfolio and Pipeline at the ASCO20 Virtual Scientific Program [Merck] ASCO Plenary Session to Feature Phase 3 Data for KEYTRUDA® (pembrolizumab) in MSI-H/dMMR Colorectal Cancer.
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).
bluebird bio to Present Updated Results From Pivotal Phase 2 KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma During ASCO20 Virtual Scientific Program [bluebird bio] Biologics License Application under review with U.S. Food and Drug Administration (FDA).
	6.15 LUTTE CONTRE LES CANCERS - COVID-19
Androgen-deprivation treatments for prostate cancer could protect men from COVID-19 [EurekAlert!] "We decided to publish this study because it provides a rationale to evaluate the efficacy of ADT prospectively in patients infected with COVID-19. Nevertheless, the study does not provide a definitive conclusion about the role of ADT in patients infected with COVID-19, and this class of drugs should not be used for this purpose until prospective trials have confirmed its efficacy."
More than 1,000 clinical trials were stopped by the pandemic — including dozens in PhIII [EndPoints] We’ve been hearing plenty of anecdotal evidence of the damage done by the Covid-19 outbreak globally to drug R&D. But a researcher now based in Berlin trawled the data available online and came up with a startling conclusion: at least 1,099 trials have been halted by the coronavirus.
Survey: Half of Cancer Researchers Report Their Work is on Hold [ACS] In early April 2020, the ACS sent a survey out to 744 current grantees via e-mail; 488 grantees responded, yielding a 66% response rate.