Onco Actu du 6 juin 2016 - spécial ASCO

	5.5.1 ASCO (général)
CancerLinQ LLC and CI4CC Launch Collaboration to Transform Cancer Data [ASCO] Collaboration convenes the medical and data science communities to drive focused efforts in oncology informatics and advance solutions for cancer care.
ASCO’s CancerLinQ™ Extends its Reach – 58 Oncology Practices, 750,000 Patient Records, 1,000 Providers Under Contract, New Partnership Launch With the Nation’s Leading Cancer Informatics Association [ASCO] CancerLinQ has completed agreements with 58 oncology practices, representing 1,000 providers under contract in 39 states and the District of Columbia, and continues to actively recruit practices nationwide. Participants range from small private practices to some of the nation’s leading cancer centers including, most recently, Intermountain Healthcare.
	5.5.10 ASCO (hémato)
Novel Daratumumab-Based Regimen Slows Multiple Myeloma Progression [ASCO] Longer patient follow up is needed to determine the impact of this daratumumab combination on patient survival. A clinical trial that combines daratumumab with another standard therapy for recurrent multiple myeloma is underway.
VYXEOS scores a 10 over 7+3 [The OBR Blog] Thus, while VYXEOS sets a high survival benchmark in elderly, high-risk AML patients, this cytotoxic agent still leaves some room for targeted agents such as volasertib (which targets polo-like kinase), ganetespib (which targets heat-shock protein 90), and vadastuximab talirine (which targets CD33) with potentially less toxicity to enter into the same space if they too can demonstrate significant survival benefits, although notably these drugs are all being compared with low-intensity, single-agent therapies in their ongoing pivotal trials.
CASTOR Shines in Relapsed/Refractory Multiple Myeloma [The OBR Blog] Darzalex utilization is currently reserved for fourth-line; however, results from the CASTOR trial are practice changing, and these data suggest that DVd should be considered a new standard of care for relapsed/refractory multiple myeloma patients currently receiving Vd alone.
Juno Therapeutics’ Defined Composition CD19 Product Candidates Demonstrate Encouraging Clinical Outcomes and Tolerability [Juno] Updated results from a randomized Phase I/II study examining JCAR014 in patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma (NHL), and chronic lymphocytic leukemia (CLL) will be presented.
Juno Therapeutics’ Investigational CAR T Cell Product Candidate JCAR015 Shows High Response Rates in Adults with B-cell ALL [Juno] In the Phase I study, presented by lead investigator Jae H. Park, M.D., of Memorial Sloan Kettering Cancer Center, 51 adult patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL) were treated with either cyclophosphamide or fludarabine/cyclophosphamide followed by an infusion of JCAR015.
Pooled Data from Meta-Analysis Suggest Significant Overall Survival Benefit of Investigational REVLIMID® Maintenance Following Autologous Stem Cell Transplant in Multiple Myeloma [Celgene] Analysis of three phase III studies presented at ASCO annual meeting shows a 26% reduction in the risk of death, representing an estimated 2.5-year increase in median survival versus placebo or no maintenance.
Novartis data show more than 50 percent of eligible Ph+ CML patients maintain Treatment-free Remission (TFR) after stopping Tasigna® [Novartis] These studies evaluated the potential to maintain molecular response (MR) after stopping therapy in adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase who achieved a sustained deep level of molecular response with Tasigna - a concept called TFR.
J&J myeloma drug, in combo regimen, delays worsening of the disease [Reuters] Some 19 percent of patients in the Darzalex group showed no further sign of disease, versus 9 percent of those taking Velcade and dexamethasone. Significant disease reduction was seen in 83 percent taking the Darzalex regimen, versus 63 percent in the two-drug combination.
	5.5.11 ASCO (SNC]
Elderly Patients With Glioblastoma Live Longer With Chemoradiation Using Temozolomide [ASCO] This is the first study to test the combination of temozolomide and radiation therapy in older adults, who account for half of all patients with this disease. While side effects were slightly greater among patients receiving temozolomide, overall quality of life was similar in both patient groups.
Giving chemotherapy after radiotherapy improves survival for patients with rare brain tumour [Cancer Research UK] "It wouldn’t have been possible for our researchers to discover and develop temozolomide without the generous donations of our supporters. And thanks to research like this we hope to be able to increase survival for more patients in the future.”
Chemotherapy Improves Outcomes for Certain Patients with Rare Brain Cancer [ASCO] Patients with anaplastic glioma without 1p/19q co-‐deletion benefit from adjuvant chemotherapy, according to early results from a European phase III trial.
	5.5.12 ASCO (médico-éco)
Precision/Personalized Medicine: Can We Afford Our Success? [Dr. Len] If you think the prices of new cancer therapies at $150,000 year today is a high price, buckle up your seatbelts because the costs could likely go higher.
Why Don’t We Pay As Much Attention To Prevention And Better Cancer Care As We Do To The Next Great New Cancer Drug? [Dr. Len] Let’s face it: the return on an investment into prevention and adequate care is more difficult to demonstrate. It isn’t glamorous. It isn’t flashy. It doesn’t get headlines.
Combination Cancer Drug Therapies Raise Cost Concerns [Wall Street Journal] In an interview, AbbVie Chief Executive Richard Gonzalez acknowledged the high cost of multidrug combinations. “In the grand scheme of things, it’s worth it” if they lead to cures or long remissions, he said. An AbbVie spokesman said the Imbruvica-Venclexta combination is in early clinical studies, and that no cost has been set.
	5.5.14 ASCO (vessie)
Patients With Advanced Bladder Cancer Benefit From Anti-PD-L1 Immunotherapy [ASCO] With a median follow-up of 14.4 months, 28 out of 119 (24%) patients responded to the treatment. The longest duration of response thus far is greater than 18 months, and 21 of 28 (75%) responses were ongoing at the time of data analysis. The median overall survival was 14.8 months.
Genentech’s Cancer Immunotherapy Tecentriq™ (atezolizumab) Shrank Tumors in People with Previously Untreated Advanced Bladder Cancer [Genentech] IMvigor 210 is an open-label, multicenter, single-arm Phase II study that evaluated the safety and efficacy of TECENTRIQ in people with locally advanced or mUC, regardless of PD-L1 expression.
Promising Response Rates with Opdivo® (nivolumab) Observed in Advanced Form of Bladder Cancer from Phase 1/2 Study CheckMate -032 [BMS] Confirmed objective response rate was 24.4% in these previously treated patients who received Opdivo.
Roche therapy helps 24 percent of untreated bladder cancer patients: study [Reuters] Results of the mid-stage trial could help make the case that the drug, Tecentriq, should become the first option therapy of choice for patients with metastatic bladder cancer, according to a researcher leading the study.
	5.5.15 ASCO (biopsies liquides)
Guardant Health Maps Cautious Plans For Blood-Based Cancer Screening [Xconomy] Liquid biopsies aim to find DNA fragments shed by tumor cells into the blood stream. Proponents say this tumor DNA—referred to as circulating tumor DNA (ctDNA) or cell free DNA—is a far more reliable indicator of cancer than current screening methods, such as the images taken by mammography and lung scans, or the test for prostate-specific antigen (PSA) protein in men’s blood.
Large Guardant Health study backs use of 'liquid biopsies' [Reuters] The Guardant-backed study included samples from 15,191 patients with advanced lung cancer, breast caner, colorectal cancer and other tumors. Each provided one or more blood samples for analysis.
Liquid Biopsy May Help Guide Treatment Decisions for Advanced Solid Tumors [ASCO] The study received funding from Guardant Health, Inc., which produces the test used in the study.
‘Liquid’ Cancer Test Offers Hope for Alternative to Painful Biopsies [NY Times] The liquid biopsies are not currently used to diagnose cancer but rather to monitor disease progression or to detect genetic mutations in the tumor that could suggest which drug should be used to treat the disease.
	5.5.16 ASCO (médecine de précision)
Innovative Direct-to-Patient Outreach May Accelerate Breast Cancer Research [ASCO] “Recruiting thousands of patients to a study in a matter of months is a remarkable achievement and the quantity of data obtained from patients treated in the real-world, including information from those who responded exceedingly well to certain treatments, could be a source of insight as we push forward in our path towards precision therapy.”
Defining cancers based on genetic ‘fingerprint’ could help personalise treatment [Cancer Research UK] While personalised treatment and genetic tests are already available for some cancers, Johnson added that there was still work to be done to understand how the approach can be offered to all patients who need it.
Precision Medicine Approach May Expand Therapeutic Options for Patients [ASCO] MyPathway is an ongoing non-randomized, open-label trial that evaluates four treatment regimens in patients with advanced cancer for whom no beneficial treatment is available. This is a nationwide study with 39 currently participating sites.
'Most exciting cancer treatment since chemotherapy' could save patients using DNA tests [The Telegraph] Experts said the promise shown by “precision medicine” was “the most exciting thing since chemotherapy” meaning that in future, patients could be saved by £200 gene tests.
	5.5.17 ASCO (pancréas)
Halozyme Presents Stage One Efficacy And Safety Analysis Of Phase 2 Clinical Study In Metastatic Pancreatic Cancer Patients Treated With PEGPH20 [Halozyme] While the sample size remains small, the median PFS and ORR continue to favor the PEGPH20 combination treatment arm compared to the standard of care AG arm.
Data Presented at ASCO 2016 Builds upon Foundation of Abraxane® Plus Gemcitabine as a First-Line Treatment in Patients with Metastatic Pancreatic Cancer [Celgene] Multiple presentations evaluate the treatment sequence with ABRAXANE plus gemcitabine in the first line setting and as a foundation for investigational combinations.
Cancer Research UK trial shows improved 5 year survival for pancreatic cancer patients [Cancer Research UK] "The difference in short term survival may seem modest, but improvement in long-term survival is substantial for this cancer."
Drug combination may extend pancreas cancer survival, trial finds [The Guardian] Liverpool University-led study found mix of two off-patent drugs upped five-year survival rate from 16% to 29% of patients.
Chemotherapy Combination With Capecitabine Extends Survival After Pancreatic Cancer Surgery [ASCO] The median overall survival was 28.0 months with the combination regimen vs. 25.5 months with gemcitabine alone. The estimated 5-­‐year survival rates were 28.8% vs. 16.3% in the two groups.
	5.5.2 ASCO (sein)
Breast cancer: Taking hormonal drugs for up to 15 years can reduce risk - study (BBC News] Experts described it as a "big deal" that will change treatment for millions of women. But they warned there were risks, including osteoporosis.
Lilly Announces Results from MONARCH 1 Trial of Abemaciclib Monotherapy [Lilly] At the final analysis of response (minimum of 12 months follow-up), patients treated with abemaciclib achieved an ORR of 19.7 percent (95% confidence interval (CI): 13.3 - 27.5%), with a median time to response of 3.7 months and a median DoR of 8.6 months.
Major weight-loss cancer trial starting [BBC News] Around 3,200 women will take part, with half of them shifting a tenth of their body weight. Experts said the trials were vital as it was still unclear if weight made a difference.
Trial to investigate link between weight, fitness and cancer recurrence [ The Guardian] The studies followed women who went on a diet and started taking exercise after cancer but they did not randomly assign women to a fitness regime or not, so it is possible those who did well were also better at taking their drug treatment.
Ten Years of Hormone Therapy Reduces Breast Cancer Recurrence Without Compromising Quality of Life [ASCO] Overall survival was not significantly different in MA.17R between the two groups but Dr. Goss notes that because of the slow chronic relapsing nature of hormone-receptor positive breast cancer, overall survival has proved difficult to demonstrate in clinical trials.
Breast cancer study shows benefit to extended treatment with aromatase inhibitors [STAT] In a randomized controlled trial, 959 women were given the drug and 959 a placebo. Thirteen of the women taking the drug for an additional five years developed breast cancer in the opposite breast during the study, compared with 31 taking the placebo; 55 and 68, respectively, developed a recurrence of cancer in the original breast.
Study Finds Mylan’s ‘Biosimilar’ Drug Comparable to Roche Cancer Medicine [Wall Street Journal] Development marks milestone in effort to bring cheaper versions of cancer treatments to market.
Copycat biotech cancer drug works as well as Roche original: study [Reuters] In the new study, nearly 70 percent of trial patients responded to MYL-14010, meaning their tumors shrank, compared with a 64 percent response rate for Herceptin. Serious side effects occurred in 38 percent of patients treated with the biosimilar and 36 percent of patients given Herceptin, also known as trastuzumab.
Biosimilar Shows Comparable Efficacy, Safety to Trastuzumab in Advanced Breast Cancer [ASCO] A biosimilar trastuzumab antibody (MYL-­1401O) is comparable in efficacy and safety to the FDA-‐approved targeted breast cancer drug trastuzumab (Herceptin) in women with HER2-­positive advanced breast cancer, according to a randomized phase III study.
Breast cancer drugs should be given for 10 years, study shows [The Guardian] Goss believes the findings should change practice. He said: “Aromatase inhibitors are now readily available around the world and therefore our results will further improve the outcome of women with breast cancer globally. It will help tens of thousands of women. It will have an enormous impact.”
Extending Estrogen Suppressor May Aid Breast Cancer Patients, Study Says [NY Times] “I think this is one of those situations where you have a new approach that probably makes sense for some women and probably doesn’t make sense for a lot of women. You have to be careful not to over-treat everyone.”
Mediterranean diet may help stop breast cancer coming back, study says [The Guardian] The cancer researchers at Piacenza hospital, Italy, found that after three years, 11 women from the group eating a normal diet suffered a return of their breast cancer, while none of those eating a Mediterranean diet did.
	5.5.4 ASCO (immunothérapies)
Genetic chaos in tumours could predict responses to immunotherapy (Cancer Research UK] “Finding a potential marker that flags which patients are more likely to respond is crucial, and larger studies to test if the genetic chaos inside tumours is that marker are now needed.”
New Data from Phase 2 Study Evaluating KEYTRUDA® (pembrolizumab) for the Treatment of Cancers Deficient in DNA Mismatch Repair Show Durable Responses Across a Range of Cancers [Merck] The KEYTRUDA (pembrolizumab) clinical development program includes more than 30 tumor types in more than 270 clinical trials, including more than 100 trials that combine KEYTRUDA with other cancer treatments.
Pfizer Presents Data from Phase 1b Trial Investigating Utomilumab (a 4-1BB agonist) in Combination with a Checkpoint Inhibitor [Pfizer] Of the 23 patients enrolled in the trial, six had a confirmed complete or partial response. The majority (four of six) of these responses lasted at least six months, with two patients maintaining their response for nearly one year at the time of data cut off.
Doubling-up on cancer immunotherapy shows promise, but side effects still a challenge [Cancer Research UK] Dr David Spigel, from the Sarah Cannon Research Institute, urged caution that it may be too soon to be sure of any survival benefit due to the small numbers of patients in the study. And Cancer Research UK’s Professor Peter Johnson added that an important next step will be to work out why some patients’ tumours respond, and others don’t.
Cancer treatment untested in many patients with immune problems [Reuters] The safety and effectiveness of a new cancer treatment known as immunotherapy is largely unknown in patients with autoimmune diseases, researchers say - and that might account for up to a quarter of individuals with lung cancer.
Cancer cell therapies could be approved next year: Juno, Kite Pharma [Reuters] In interviews with Reuters, Kite Pharma Inc and Juno Therapeutics Inc both said they could receive initial regulatory approvals next year for a type of immunotherapy treatment known as chimeric antigen receptor T-cell (CAR-T) therapies.
	5.5.5 ASCO (gastro-intestinal)
First Presentation of Phase 2 CheckMate -142 Study Evaluating Opdivo® (nivolumab) Alone or in Combination with Yervoy® (ipilimumab) Demonstrates Encouraging Clinical Activity in MSI-High Metastatic Colorectal Cancer [BMS] Investigator-assessed objective response rate for MSI-high metastatic colorectal cancer patients was 25.5% for Opdivo monotherapy and 33.3% for Opdivo in combination with Yervoy.
New pre-surgery technique may make colostomy bags redundant for emergency bowel cancer patients [Cancer Research UK] "We’re pleased to see that this could be a way of reducing the risk of patients needing a colostomy bag after their surgery – which is a huge improvement to patients’ day-to-day lives."
Bowel cancer: Stents 'may prevent need for colostomy bags' [BBC News] Bowel cancer patients may avoid the need for colostomy bags if they are first treated by having an expandable tube inserted at the site of their blockage, cancer doctors have said.
	5.5.6 ASCO (peau-mélanome)
New Data for KEYTRUDA® (pembrolizumab) in Combination with Talimogene Laherparepvec, Dabrafenib Plus Trametinib, or Low-Dose Ipilimumab in Advanced Melanoma Presented at 2016 ASCO Annual Meeting [Merck] “These encouraging early data point to the potential for KEYTRUDA to become an important component of combination therapy in melanoma.”
	5.5.7 ASCO (gynéco)
Adding Intraperitoneal Chemotherapy Slows Ovarian Cancer Progression [ASCO] This randomized phase II trial compared the efficacy and side effects of two combination chemotherapy regimens in patients with stage IIB-­‐IV epithelial ovarian cancer. The majority (82%) of women had stage IIIC disease (cancer spread into the intraperitoneal cavity).
	5.5.8 ASCO (poumon)
AbbVie's New Lung Cancer Drug May Extend Patients' Lives, But Could Disappoint Investors [Forbes] Many on Wall Street are likely to find that 1-month survival benefit disappointing.
New Antibody Drug Conjugate Shows Early Promise in Small Cell Lung Cancer [ASCO] Potential First Predictive Biomarker Identified for SCLC.
Early-Phase Immuno-Oncology Studies of Lilly's ALIMTA® (pemetrexed) and CYRAMZA® (ramucirumab) with Merck's KEYTRUDA® (pembrolizumab) Show Encouraging Results in Non-Small Cell Lung Cancer [Lilly] Responses Observed Regardless of PD-L1 Expression.
ARIAD Presents Data from Mutational Profiling in Crizotinib-Resistant Patients Treated with Investigational Medicine Brigatinib Showing Similar Response Rates in Patients with and without Secondary ALK Mutations [ARIAD] Brigatinib Achieves Confirmed Response in Patient with G1202R Mutation that Emerges Following Treatment with Current Approved Therapies.
ARIAD Presents Long-Term Phase 1/2 Trial Follow up on Investigational Drug Brigatinib with Median Time on Treatment of 17 Months in ALK+ NSCLC Patients [ARIAD] The data presented at ASCO include safety analyses on all patients in the trial (n=137) and efficacy analyses on all patients with ALK+ NSCLC (n=79).
New KEYTRUDA® (pembrolizumab) Data from KEYNOTE-010 and KEYNOTE-001 in Advanced Non-Small Cell Lung Cancer, Including Survival Data, To Be Presented at 2016 ASCO Annual Meeting [Merck] KEYNOTE-001 Findings Show Responses Are Durable and Include Two Year Overall Survival Data for KEYTRUDA.
New Data Evaluating KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Non-Small Cell Lung Cancer Demonstrate Response Rates Ranging from 48 to 71 Percent [Merck] The findings presented at ASCO 2016 were based on 74 patients who were treated with KEYTRUDA and one of three different chemotherapy regimens in the phase 1b portion of the study.
Opdivo® (nivolumab) and Yervoy® (ipilimumab) Combination Regimen Shows Clinically Meaningful Responses in First-Line Advanced Non-Small Cell Lung Cancer, In Updated Phase 1b Study CheckMate -012 [BMS] Confirmed objective response rate in patients with >1% PD-L1 expression for both Opdivo and Yervoy combination regimen cohorts was 57%, a doubling of response rate previously reported in Opdivo monotherapy arm.
Twice a day radiotherapy halves treatment time and is equally good at treating small cell lung cancer [Cancer Research UK] The CONVERT clinical trial – the largest trial ever completed in this group of patients – looked to find the best way of giving radiotherapy alongside chemotherapy for patients with small cell lung cancer.
	5.5.9 ASCO (autres organes)
Long-Term Survival and Improvement in Quality of Life Observed with Opdivo® (nivolumab) in Advanced Renal Cell Carcinoma Patients Based on New Data Presented at the 2016 ASCO Annual Meeting [BMS] More than one-third (34%) of previously treated advanced renal cell carcinoma patients who received Opdivo were alive at five years, in the Phase 1 study, CA209-003.
Double Stem-Cell Transplant Improves Outcomes for Children with High-Risk Neuroblastoma [ASCO] At 3 years, 61.4% of patients who received a double transplant were alive and cancer-free, compared to 48.4% of those who received a single transplant. Side effects were similar between single and double transplant.
Exelixis and its partner Ipsen announce phase 3 trial results of CABOMETYX™ (cabozantinib) tablets demonstrating significant overall survival benefit for previously treated patients with advanced renal cell carcinoma presented at ASCO [Ipsen] Details of clinically meaningful increase in overall survival from METEOR trial to be presented in an oral abstract session and published simultaneously in The Lancet Oncology.