Onco Actu "Spécial ASCO" du 2 juin 2015

	5.5 ASCO
First Version of CancerLinQ™ Data Analytics Platform Debuts at 51st ASCO Annual Meeting [ASCO] CancerLinQ Completes Agreements with Additional Oncology Practices for Roll-Out with 500,000 Patient Records; Opens California Office.
	5.5.1 ASCO (général)
Beware the hype over 'miracle' cancer drugs [The Telegraph] The concept that there will be the sudden discovery of a miraculous breakthrough for cancer is fuelled by hype from the drug industry. There are now over ten cancer drugs, most not available on the NHS, that cost nearly £10,000 a month. They give at the most a few weeks' or months' more relatively poor-quality life.
	5.5.1.1 ASCO (général) - Industriels
ASCO 15: The top 10 setbacks, advances and head scratchers [FierceBiotech] We saw a number of big winners and losers over the weekend.
Findings Presented at 2015 ASCO Annual Meeting Add to Breadth of KEYTRUDA® (pembrolizumab) Data; Anti-Tumor Activity Now Demonstrated in 13 Different Tumor Types [Merck] New Data Presented at ASCO in Multiple, Difficult-to-Treat Cancers, including Small Cell Lung, Esophageal and Ovarian Cancers. Registrational Studies for KEYTRUDA Ongoing in Eight Different Tumor Types.
ASCO '15 Report Card: Grading Biotech and Drug Stocks at Cancer Drug Confab [TheStreet] I spent a long weekend in chilly, rainy Chicago listening to endless cancer-drug data presentations at the American Society of Clinical Oncology (ASCO) annual meeting. Here are my flash impressions on the biotech and drug companies.
	5.5.10 ASCO (hémato)
Zydelig® in Combination With Ofatumumab Improves Progression-Free Survival in Previously-Treated Patients With Chronic Lymphocytic Leukemia [Gilead] In Study 119, there was a 73 percent reduction in the risk of disease progression or death in patients receiving Zydelig in combination with ofatumumab compared to ofatumumab alone.
Juno amps up its CAR-T tech in drive toward a pivotal test [FierceBiotech] In an interview with FierceBiotech, Juno EVP of development and portfolio strategy Mark Frohlich and CFO Steve Harr say they'll be taking what they learned from this study and applying it to a study for JCAR017, a drug that Harr adds has all the characteristics of a therapy that they can manufacture more readily than JCAR014.
Juno's Investigational CAR T Cell Product Candidate JCAR014 Demonstrates Encouraging Clinical Responses and Translational Insights in Patients With B-Cell Cancers [Juno] JCAR014 is in an ongoing Phase I/II trial in patients with r/r B cell malignancies, including ALL, NHL and CLL. Juno intends to continue enrolling patients in this trial through 2015 in order to gain insights into various factors that may improve the expansion and persistence of these CAR T cells in the body.
Novartis highlights CTL019 data showing its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma [Novartis] Data show adult patients may achieve durable response rates, with 13 of 19 evaluable patients with relapsed/refractory non-Hodgkin lymphomas responding to therapy.
Ibrutinib (IMBRUVICA®) HELIOS Interim Analysis Study Data Show Significant Reductions in Risk of Progression or Death in Patients with Previously-Treated Chronic Lymphocytic Leukemia [Johnson & Johnson] Data from the Phase 3 CLL3001 (HELIOS) trial demonstrated that the combination of ibrutinib (IMBRUVICA®) plus bendamustine and rituximab (BR) reduced the risk of progression or death by 80% and also significantly improved overall response rate (ORR) versus placebo plus BR in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
Data Show Daratumumab Achieved a Pronounced Overall Response Rate as a Single-Agent with Tolerable Safety Profile in Heavily Pre-Treated Multiple Myeloma Patients [Johnson & Johnson] Data from the international, multi-center, open-label, two-part, single-arm Phase 2 MMY2002 (SIRIUS) trial show treatment with single-agent daratumumab – an investigational, human anti-CD38 monoclonal antibody – achieved an overall response rate (ORR) of 29.2 percent (95% CI, 20.8-38.9), as assessed by an independent review committee, in heavily pre-treated patients with multiple myeloma.
Novartis, Juno Killer T-Cells Show Promise In Another Blood Cancer [Forbes] The genetically altered, cancer-killing T-cells known as CARTs showed dramatic results in non-Hodgkin lymphoma as the two leading players, the Swiss drug giant Novartis and the Seattle upstart Juno Therapeutics, pushed forward with new clinical trials.
	5.5.12 ASCO (médico-éco)
Anthem Plan for Containing Cancer Drug Costs Shows Promising Signs [Wall Street Journal] The poster that Anthem is presenting at ASCO – which notes the different drug regimens – suggests “additional interventions may be needed to increase program participation and pathway adherence.”
Top Oncologist To Convention Of Doctors, Pharma Execs: New Cancer Treatments Cost Too Damn Much [Forbes] I don’t agree that our national inability to face death is the main problem here. Instead, it’s the baroque system of paying for medicines that we’ve created because of our fear of socialist price controls.
	5.5.13 ASCO (divers)
Cancer trials aim to shore up 'precision medicine's' base of evidence [LA Times] With a price tag at "around $30 [million] to $40 million," according to Doroshow, the NCI-MATCH trial will enroll as many as 3,000 participants in its first wave starting next month.
U.S. Cancer Study to Match Existing Drugs to Genetic Mutations [Wall Street Journal] The announcement came at the annual meeting of the American Society of Clinical Oncology, which is launching a similar study called TAPUR, in which five pharmaceutical companies so far have agreed to provide a total of 13 genetically targeted drugs already on the market.
NCI-MATCH Trial Links Targeted Drugs to Mutations [National Cancer Institute] NCI-MATCH is a phase II trial with numerous small substudies (arms) for each treatment being investigated. It will open with approximately 10 substudies, moving to 20 or more within months.
ASCO Launches First-ever Clinical Trial: Aims to Learn from Patients with Advanced Cancer Who Lack Standard Treatment Options [ASCO] The ASCO-sponsored prospective, non-randomized clinical trial will collect information on the anti-tumor activity and toxicity of commercially available, targeted cancer drugs in a range of cancer types, including any advanced solid tumor, multiple myeloma, or non-Hodgkin lymphoma with a genomic variation known to be a drug target.
Oncotype DX® Presentations at ASCO in Breast and Prostate Cancer Reinforce Genomic Health's Leadership in Optimizing Cancer Treatment [Genomic Health] New Data Include Two Positive Studies in DCIS Breast Cancer and Report of Baseline Characteristics in NCI's TAILORx Trial Examining Oncotype DX across Race and Ethnicity.
Tests for new cancer drugs not reliable enough, doctors say [Reuters] Dr. Richard Pazdur, the U.S. Food and Drug Administration's oncology chief, also cautioned that there is still a great deal of uncertainty about how to best measure for PD-L1.
Transition to gene-based cancer treatment may not be simple [Reuters] Dr. Bert Vogelstein, a cancer geneticist at Johns Hopkins University in Baltimore, said there is scant evidence that matching a patient's mutation to a targeted drug improves care. "It's definitely an unproven assumption and we ought to test it," Vogelstein said.
Cancer trials aim to shore up 'precision medicine's' base of evidence [LA Times] With a price tag at "around $30 [million] to $40 million," according to Doroshow, the NCI-MATCH trial will enroll as many as 3,000 participants in its first wave starting next month.
Tests for new cancer drugs not reliable enough, doctors say [Reuters] Dr. Richard Pazdur, the U.S. Food and Drug Administration's oncology chief, also cautioned that there is still a great deal of uncertainty about how to best measure for PD-L1.
Large U.S. cancer trial to match genetic glitches to targeted drugs [Reuters] Overall, trial investigators plan to sequence the DNA of about 3,000 patients nationwide during the full course of the trial, known as NCI-MATCH. Of those, they plan to enroll about 1,000 patients in the various drug treatment arms in the trial.
ASCO Presenter Touts Comparative Genomics with Dog, Sea Lion Models as Source of Cancer Clues [Genome Web] Bolstered by such results, Breen and his colleagues are now developing additional DNA and RNA resources in dogs and other animals.
	5.5.2 ASCO (sein)
Puma Biotechnology Announces Phase III Trial of PB272 in Extended Adjuvant Breast Cancer (ExteNET Trial) Demonstrates Statistically Significant Improvement in Disease Free Survival [Puma] The ExteNET trial randomized 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year.
New Enzalutamide Data in Triple-Negative Breast Cancer Presented at the 2015 American Society of Clinical Oncology Annual Meeting [Astellas] The Phase 2 open label single arm, multicenter trial enrolled 118 women with advanced TNBC in two stages. The primary endpoint of the trial was clinical benefit rate at 16 weeks (CBR16), defined as the proportion of women with a complete response (CR), partial response (PR) or stable disease for at least 16 weeks.
Puma Bio Breast Cancer Drug Given Rough Treatment at ASCO '15 [TheStreet] The benefit for breast cancer patients treated with Puma's neratinib was "awfully small" for a drug that causes "a lot of diarrhea," said Dr. Harold Burstein, a breast cancer expert from the Dana-Farber Cancer Institute.
'Amazing' new breast cancer drugs could extend life of sufferers [TheTelegraph] When the drug Perjeta was given to such women, in combination with standard treatment, tumours disappeared in 40 per cent of cases, without surgery.
Taking extra breast tissue halves need for second cancer surgery [Reuters] "It's really hard to ignore Level 1 evidence that shows you can cut the reoperation rate in half without changing the cosmetic outcome or increasing complications. That's kind of a no-brainer."
	5.5.3 ASCO (prostate)
OncoGenex Announces Data from the Phase 3 SYNERGY Trial Showing a Survival Benefit with Custirsen in Patients with Poor Prognosis [OncoGenex] The analysis, exploring the effect of clusterin inhibition in men at risk for poor outcomes, showed that over 40 percent of men in the trial had at least two of five common risk factors for poor prognosis. In these men, the analysis found a 27 percent lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone.
	5.5.4 ASCO (immunothérapies)
Immunotherapy drugs show continued promise [Cancer Research UK] Professor Peter Johnson, Cancer Research UK’s chief clinician, said the finding suggests the beginnings “of a whole new era for cancer treatments.”
Immunotherapy: the big new hope for cancer treatment [The Guardian] Excitement over new cancer drugs is a dangerous thing. There have been melanoma drugs before that were greeted as miracle cures. But the enthusiasm for immunotherapy may be better placed because this is a whole new way of tackling cancer.
	5.5.5 ASCO (gastro-intestinal)
Radioactive particles combined with chemotherapy slow advanced bowel cancer growth in the liver [Cancer Research UK] The study included 530 people and found that in six per cent of cases the combined therapy sent the cancer into remission - three times more frequently than when only chemotherapy was used.
	5.5.6 ASCO (peau)
Immunotherapy drug combo could combat melanoma [NHS Choices] The study is ongoing and it has yet to be seen whether the drug combination, or nivolumab alone, can increase how long people live overall.
Cancer patient's tumours disappeared with groundbreaking treatment [The Telegraph] After taking part in a trial at the Royal Marsden with a combination of two immunotherapy drugs, nivolumab and ipilimumab, the tumours disappeared in a matter of weeks. Ms Brown, who is widowed with two children and one grandchild. said she felt like a “death sentence” had been lifted. “It was miraculous,” she said.
	5.5.8 ASCO (poumon)
Foundation Medicine Identifies Patients Likely to Respond to Certain MET Inhibitor Targeted Therapies; Durable Responses in Non-Small Cell Lung Cancer (NSCLC) Presented at ASCO Annual Meeting [Foundation Medicine] Data Support Role of MET Exon 14 Alterations as a Viable Therapeutic Target and Highlight Need for Reimbursement of Comprehensive Genomic Profiling in Leading Cancer Killer.
ARIAD Presents Updated Clinical Data on brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer at the 2015 ASCO Meeting [ARIAD] The current results include more mature efficacy data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients, as well as more extensive safety data for all patients in the trial.
Novartis presents new data at ASCO for Zykadia® and combination of Tafinlar® and Mekinist® in certain NSCLC patients with unmet needs [Novartis] The results of the Zykadia studies - ASCEND-2 and ASCEND-3 - reinforce the efficacy of the medicine in patients with anaplastic lymphoma kinase-positive (ALK+) NSCLC who had received previous treatment with an ALK inhibitor and in those receiving an ALK-targeted therapy for the first time.
AbbVie Presents Phase 2 Results from Study of Investigational Medicine Veliparib in Patients with Non-Small Cell Lung Cancer at the American Society of Clinical Oncology Annual Meeting [AbbVie] "Veliparib showed interesting results when combined with chemotherapy in a subset of patients with smoking history."
	5.5.9 ASCO (autres organes)
OncoGenex Announces Data from Borealis-1™ Trial Showing Clinical Benefit with Apatorsen in Metastatic Bladder Cancer [OncoGenex] The trial enrolled approximately 180 patients with documented metastatic or locally inoperable transitional cell carcinoma (TCC) of the urinary tract who had not previously received chemotherapy for metastatic disease and were not candidates for potentially curative surgery or radiotherapy.