Onco Actu du 11 septembre 2017 - Spécial ESMO

	5.6 ESMO
ESMO 2017 Press Release: “Triggers”: a New Tool to Assess Cancer Patients’ Palliative Needs [ESMO] he Triggers tool allows oncologists to assess their patients’ needs in this respect at a much earlier stage, and to potentially refer them to specialist palliative care alongside active treatment.
ESMO 2017 Press Release: Patients Feel Psycho-social Impact of Chemo More Acutely Than Physical Side Effects [ESMO] ESMO will soon publish a position paper on the need to integrate supportive and palliative care for patients, from diagnosis and throughout the course of the disease.
ESMO 2017 Press Release: Cancer Patients Struggle with Key Aspects of Clinical Trial Methodology [ESMO] "Over half of previous medical trial participants and 73 percent of those who had never been on a cancer clinical trial did not understand that in a randomised trial, the treatment given was decided by chance.”
ESMO 2017 Press Release: Study Shows ESMO Magnitude of Benefit Scale Can Be Used to Grade Orphan Drugs [ESMO] The study included 63 drugs approved by the US Food and Drug Administration (FDA) between 2006 and 2016 for 118 solid tumour indications, of which 54 (46%) were given orphan designation.
	5.6.10 ESMO - Vessie
Lilly Builds Upon Body of Clinical Evidence for CYRAMZA® (ramucirumab) with Phase 3 RANGE Data Demonstrating Superior Progression-Free Survival in Advanced or Metastatic Urothelial Cancer [Lilly] RANGE data presented at ESMO 2017 Congress Presidential Symposium and to be published in The Lancet.
Merck's Keytruda extends survival edge on its bladder cancer rivals [FiercePharma] Keytruda, though, is the only one of the lot with overall survival data to back up its case, and it’s not for lack of trying from its rivals.
ESMO 2017 Press Release: Ramucirumab plus Docetaxel Improves Progression-free survival in Urothelial Cancer [ESMO] The primary endpoint of investigator-assessed progression-free survival was significantly prolonged with ramucirumab plus docetaxel compared to placebo plus docetaxel (4.07 months versus 2.76 months; hazard ratio, 0.757).
ESMO 2017 Press Release: Mature Results Favour Pembrolizumab As Second-line Treatment For Bladder Cancer [ESMO]
ESMO 2017: Pembrolizumab Continues to Show Greater Benefit over Chemotherapy in Recurrent, Advanced Urothelial Carcinoma [ESMO] Mature results from KEYNOTE-045 confirm pembrolizumab significantly improves overall survival versus chemotherapy.
ESMO 2017: Ramucirumab Improves PFS in Patients with Platinum Refractory Advanced Urothelial Carcinoma [ESMO] Results show encouraging results when ramucirumab is added to docetaxel in phase III RANGE trial.
	5.6.11 ESMO- Rein
Exelixis and Ipsen Announce Results from Phase 2 CABOSUN Trial of Cabozantinib versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma at ESMO 2017 [Exelixis] Cabozantinib provided statistically significant improvement of progression-free survival, with a 52 percent reduction in the rate of progression or death compared to sunitinib.
Bristol-Myers' Opdivo-Yervoy cocktail slashes kidney cancer death risk by 37% [FiercePharma] Why a surprise? Because in August, the company unveiled mixed results from the same trial.
Opdivo Plus Yervoy Combination Demonstrated Superior Overall Survival and Showed Durable Responses in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma in Phase 3 CheckMate -214 Trial [BMS] The combination also significantly improved overall survival in all randomized patients.
ESMO 2017: Progression-free Rate Unaffected by Sequence of Cytoreductive Nephrectomy and Sunitinib in Patients with Synchronous mRCC [ESMO] Overall survival and post surgical complication rates were better with deferred versus immediate cytoreductive nephrectomy while progression rates at 16 and 28 weeks were not significantly different between both sequences.
Bristol-Myers posts data on an upset checkpoint combo victory in frontline kidney cancer [EndPoints] The update from Bristol-Myers marks the latest in a complex set of twists and turns for Bristol-Myers Squibb, as all of the companies in the space race for the lead position in various cancer types.
ESMO 2017: Nivolumab Plus Ipilimumab versus Sunitinib in First-Line Treatment for Advanced or Metastatic RCC [ESMO] In CheckMate-214, combined nivolumab and ipilimumab shows considerable benefit in intermediate- and poor-risk patients with advanced or metastatic renal cell carcinoma.
Bristol's drug cocktail cuts kidney cancer death risk 37 percent [Reuters] Significantly, the immunotherapy combination caused fewer serious side effects than Sutent, lead researcher Bernard Escudier of the Institut Gustave Roussy in France said. He believes the efficacy and safety profile mean Opdivo plus Yervoy should become a new first-line standard of care for patients with advanced disease.
	5.6.12 ESMO - Observation
ESMO 2017 Press Release: Study Identifies Factors that Limit Work Ability of Young Adult Cancer Survivors [ESMO] Patients diagnosed with melanoma, colorectal cancer, breast cancer stages I–III, non-Hodgkin lymphoma or leukaemia in 1985 to 2009, and alive in September 2015, were identified through the Cancer Registry of Norway.
	5.6.13 ESMO - Prostate
New Data Presented at ESMO 2017 Shows That Abiraterone Acetate Plus Prednisone Provides Benefits in Patient Reported Outcomes in Both Metastatic Hormone-Sensitive and Castration-Resistant Prostate Cancer [Janssen] "The new data from the LATITUDE clinical trial suggests that abiraterone acetate plus prednisone, in combination with androgen deprivation therapy, offers a much-needed efficacious treatment option for patients with newly diagnosed metastatic disease,” said Dr Karim Fizazi.
Prospective analysis reveals patients with mCRPC and germline mutations in DNA repair genes have a trend to poorer outcomes [ESMO] Strong responses and significantly improved QoL were observed with 177Lu-PSMA617.
ESMO 2017: Germline Mutations in DNA Repair Genes Lowers Survival in mCRPC [ESMO] Prospective analysis reveals patients with mCRPC and germline mutations in DNA repair genes have a trend to poorer outcomes.
ESMO 2017: Adding Abiraterone Acetate or Docetaxel Plus Prednisone to Standard of Care in Patients with High-Risk Prostate Cancer [ESMO] STAMPEDE head to head comparison of two beneficial combinations shows similar survival.
Two treatments for advanced prostate cancer bring equal benefits [Cancer Research UK] The results, based on analysis of data from the Cancer Research UK-funded STAMPEDE trial, show that standard hormone therapy combined with another hormone therapy called abiraterone (Zytiga) or a chemotherapy drug called docetaxel give comparable improvements in survival compared to standard hormone therapy alone.
	5.6.14 ESMO - Ovaire
ESMO 2017: Patients with Platinum Sensitive Ovarian Cancer Maintan QoL During Maintenance Niraparib Therapy [ESMO] Previously reported data show maintenance niraparib significantly improved PFS over placebo in patients with recurrent platinum-sensitive ovarian cancer.
ESMO 2017: Rucaparib Shows Clinical Benefit as Maintenance Therapy in Patients with Recurrent Ovarian Cancer [ESMO] Rucaparib delayed disease recurrence in the ITT population and across subgroups in ARIEL3 study.
ESMO 2017: Overall Survival Benefit is Seen with Olaparib in Patients with Ovarian Cancer and TP53 Disruptive Mutation Status [ESMO] An analysis of BRCA and the TP53 status in patients with ovarian cancer shows disruptive TP53 mutations associate with an overall survival benefit from olaparib treatment.
Targeted drug helps keep some advanced ovarian cancers at bay [Cancer Research UK] “These results show that rucaparib has the potential to provide an enduring and important clinical benefit in women with advanced ovarian cancer, irrespective of their tumour genetics.”
	5.6.15 ESMO - VADS
ESMO 2017 Press Release: KEYNOTE-040 Evaluates Pembrolizumab in Head and Neck Cancer [ESMO] “Even though the study did not meet its primary endpoint, I still think it is a positive trial.”
	5.6.16 ESMO - Appareil digestif
ESMO 2017: Pembrolizumab Demonstrates Antitumour Activity in Advanced Gastric Cancer as Monotherapy and Combined with Chemotherapy [ESMO] Update of KEYNOTE-059 study.
ESMO 2017: Promising Results Demonstrated with DCC-2618 in GIST [ESMO] DCC-2618, a novel pan-KIT and PDGFRα inhibitor, shows encouraging antitumour activity in heavily pretreated patients with GIST.
ESMO 2017: Adjuvant Imatinib Recommended Only for Patients with High-risk GIST [ESMO] Final results from the EORTC intergroup randomised trial.
	5.6.17 ESMO - Foie
ESMO 2017: Biomarker Analysis Reveals Different Genes are Upregulated After Lenvatinib and Sorafenib Treatment in Unresected HCC [ESMO] Lower baseline VEGF, ANG2, and FGF21 serum levels showed a non-significant trend toward better outcomes with both drugs.
	5.6.18 - Hémato
ESMO 2017: Patients Receiving Radioactive Iodine for Well-Differentiated Thyroid Cancer Have an Increased Risk of AML [ESMO] RAI administered after surgery for the treatment of WDTC associates with increased risk of developing leukaemia and AML development associates with a significantly poorer prognosis.
ESMO 2017: Biosimilar Rituximab Shows Equivalent Efficacy to Reference Rituximab in Previously Untreated Advanced Follicular Lymphoma [ESMO] Biosimilar GP2013 demonstrated an equivalent overall response rate compared to the reference drug rituximab in the ASSIST-FL study.
	5.6.2 ESMO - Divers
ESMO 2017: Tumour Subtype Specific Genetic Alterations Detected by Comprehensive Genomic Profiling [ESMO] Targetable oncogenic drivers of several tumours identified that may also associate with TKI response.
ESMO 2017: Clinical Trial Toxicity Reporting by Investigators May Not Reflect Patients’ Viewpoint [ESMO] Patient experience according to HRQoL questionnaire does not mirror investigator toxicity reporting for many symptoms.
ESMO 2017: Subtypes of Thymic Carcinomas Show Different Genomic Alterations and Tumour Mutational Burden [ESMO] Comprehensive genomic profiling identifies varied genetic alterations in thymic gland carcinoma that may be treated with targeted and immunotherapy therapies.
ESMO 2017: Large Dataset of Targetable Genomic Alterations Created Using Liquid Biopsy [ESMO] Genomic variants identified by NGS of ctDNA that have clinical implications regarding choice of treatment.
ESMO 2017 Press Release: Abdominal Fat a Key Cancer Driver for Postmenopausal Women [ESMO] Using information from national cancer registries, the study recorded 811 solid cancers in the women and showed that the ratio of abdominal fat to peripheral fat was a significant independent predictor of cancer diagnosis up to 12 years after baseline.
ESMO 2017 Press Release: Combination Immunotherapy in Second/third Line Extends Mesothelioma Survival to 15 Months [ESMO] MAPS2 was an academic, Intergroupe Francophone de Cancérologie Thoracique (IFCT)-sponsored, non-comparative randomised phase II trial of two checkpoint inhibitors in patients with MPM who had relapsed after one or two lines of pemetrexed and platinum chemotherapy.
ESMO 2017 Press Release: Licensing and Reimbursement Discrepancies Impact Patient Access to Cancer Treatment [ESMO] Conducted on behalf of Bristol-Myers Squibb, the study evaluated decisions by authorities in 11 European countries and Canada on anti-cancer medicines approved by the European Medicines Agency and Health Canada between 2006 and 2016 for six tumour types.
	5.6.4 ESMO - Poumon
AstraZeneca immunotherapy study shows benefit for niche group of lung cancer patients [STAT] Approximately one-quarter of stage III lung cancer patients do not respond to initial chemotherapy and radiation. They’re excluded from the PACIFIC study. Had they been included, the outcome seen with the Imfinzi and placebo arms of the study might have looked more similar, he says.
Merck piles on the positive Keytruda-chemo combo results in lung cancer [FiercePharma] “The bar to filing/approval is typically much higher” in Europe than it is in the U.S., increasing the importance of positive overall survival data.
AstraZeneca's Tagrisso bests rivals at holding off EGFR lung cancer growth [FiercePharma] If Tagrisso can nab a first-line EGFR nod, it would move into earlier stages of treatment and expand its eligible patient pool, which is currently limited to patients with an abnormal T790M gene, after they’ve failed on other treatments.
AstraZeneca wows with Imfinzi's 11-month survival edge in lung cancer [FiercePharma] AstraZeneca—which will be alone in the market for a good two to three year, Anderson predicts—is in prime position to benefit. The opportunity in the G7 markets tallies about 47,000 patients, he estimates.
ESMO 2017 Press Release: Osimertinib Improves Progression-free Survival in Patients with EGFR Mutated Lung Cancer [ESMO] FLAURA was a randomised phase III clinical trial comparing osimertinib to standard of care erlotinib or gefitinib as first line therapy in NSCLC patients with EGFR exon 19 or 21 mutations. The primary endpoint was progression-free survival.
ESMO 2017: Durvalumab as Consolidation Therapy Prolongs PFS in Stage III NSCLC Patients Without Progression Following Platinum-based Chemoradiotherapy [ESMO] Interim results from the PACIFIC Trial.
#ESMO17: AstraZeneca salves stinging setback with a big win in a blockbuster segment of the lung cancer market [EndPoints] Soriot demurred on giving his own estimate of what that is worth, sticking with the company’s ballpark figure of $1 billion-plus. But he also cited a market consensus that a win in this group could spur sales of more than $2 billion a year.
ESMO 2017: Improved Survival Demonstrated with NSCLC-chemotherapy in Pulmonary Large Cell Neuroendocrine Carcinoma with RB1 Wild-type [ESMO] Overall, the patients derived more benefit from chemotherapy designed to treat NSCLC than from chemotherapy for SCLC.
ESMO 2017: First-line Dabrafenib and Trametinib Shows Substantial Clinical Activity in BRAF V600E–mutated Metastatic NSCLC [ESMO] Three-fourths of patients with previously untreated BRAF V600E–mutated NSCLC, receiving a combination of a BRAF inhibitor dabrafenib plus a MEK inhibitor trametinib, achieved complete or partial response or stable disease by investigator assessment and independent review.
ESMO 2017: Front-Line Osimertinib Poised to Become Standard of Care in EGFR-Mutation Positive NSCLC [ESMO] The risk of progression was reduced with osimertinib compared to SoC in patients with advanced NSCLC and EGFR mutations.
AstraZeneca rebuilds cancer drug hopes with new lung data [Reuters] Analysts believe using Imfinzi in so-called stage III lung cancer opens up an annual sales opportunity worth around $2 billion. Importantly, AstraZeneca has a lead of two to three years over rivals in this particular area.
	5.6.5 ESMO - Mélanome & Peau
Opdivo (nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) for Patients with Resected High-Risk Melanoma in Phase 3 CheckMate -238 Stud [BMS] Opdivo decreased the risk of disease recurrence by 35% compared to Yervoy.
With Yervoy-beating data, Opdivo poised to fight melanoma's return after surgery [FiercePharma] The company also hopes to add to Opidvo’s list of approvals, and moving the therapy into the post-surgery setting could add around $1 billion in potential sales, though some of that would come from patients who might otherwise have used Yervoy.
Merck, Incyte chalk up promising melanoma data for Keytruda-epacadostat combo [FiercePharma] This new analysis centered on a cohort with advanced melanoma who had not been previously treated with immunotherapy meds in the PD-1/L1 or CTLA4 classes.
Roche announces phase III study results of Zelboraf for adjuvant treatment of BRAF V600 mutation-positive melanoma [Roche] The study did not meet its primary endpoint of significantly reducing the risk of recurrence (disease-free survival; DFS) in patients with stage IIIC melanoma (cohort 2); however, a 46% reduction in recurrence risk was observed in stage IIC-IIIB patients (cohort 1).
ESMO 2017 Press Release: Combination Targeted Adjuvant Therapy Doubles Relapse-free Survival in Stage III Melanoma [ESMO] COMBI-AD is the first clinical trial of targeted therapies for adjuvant treatment of stage III melanoma. All patients had a BRAF mutation – 91% harboured a V600E mutation and 9% had a V600K mutation, which is the typical distribution in clinical practice.
After melanoma surgery, Bristol's Opdivo offers new care standard [Reuters] The finding represents an advance for so-called PDx drugs in treating cancer at an earlier stage, before it has spread around the body. At present, the use of such drugs, which help the immune system fight tumors, is confined to metastatic disease.
ESMO 2017 Press Release: Adjuvant Nivolumab Superior to Ipilimumab in Surgically Resected Stage III/IV Melanoma [ESMO] “Nivolumab looks like a superior adjuvant melanoma regimen compared to ipilimumab from every angle. It leads to better relapse-free survival, has fewer side effects, and is well tolerated.”
Novartis posts a win, Roche a flop in skin cancer trials [Reuters] The findings suggest Novartis is gaining the upper hand in expanding its combination therapy’s use against advanced, high-risk skin cancer for which there is a distinct risk of the potentially deadly tumors emerging elsewhere on the body.
	5.6.6 ESMO - Sein
ESMO 2017: Combined Letrozole plus Palbociclib is not Better than Chemotherapy as Neoadjuvant Treatment in Luminal Breast Cancer [ESMO] Neoadjuvant treatment with letrozole/palbociclib provides low pathogical response rates but promising clinical results in luminal breast cancer.
ESMO 2017: Invasive DFS Rates Following Trastuzumab are Improved with Neratinib Over Placebo in Early Stage HER2-positive Breast Cancer [ESMO] ExteNET at 5 years demonstrates significant clinical benefit following one-year of neratinib administered after one year of trastuzumab-based adjuvant therapy.
ESMO 2017: Combined Taselisib and Letrozole Improves Response in Postmenopausal Women with ER-positive, HER-negative Early Breast Cancer [ESMO] In LORELEI, PI3K inhibition increased neoadjuvant letrozole efficacy in women with and without tumours harbouring a PIK3CA mutation.
Pfizer Presents Positive Pivotal Data for PF-05280014, an Investigational Biosimilar to Herceptin® (trastuzumab), at the European Society for Medical Oncology (ESMO) 2017 Congress [ESMO] Data from the REFLECTIONS B327-02 study demonstrates equivalence in objective response rate (ORR) for patients with HER2-positive metastatic breast cancer.
Lilly pads case for third-to-market abemaciclib with more positive breast cancer data [FiercePharma] “We think there are going to be recognizable, concerning characteristics” among patients “for whom abemaciclib might be an interesting addition to the treatment armamentarium for oncologists treating breast cancer."
ESMO 2017: TIL Levels Signal Pembrolizumab Response in Metastatic TNBC [ESMO] TIL levels in tumour samples associate with PD-L1 expression and pembrolizumab response in metastatic triple negative breast cancer.
ESMO 2017: Promising Response Rates in Patients with Metastatic TNBC Treated with Nivolumab After Induction Treatment [ESMO] Induction therapy with (low dose) chemotherapy or irradiation before nivolumab is feasible in triple negative metastatic breast cancer.
ESMO 2017: Combined Abemaciclib with NSAI Show Significant Clinical Benefit as Initial Treatment for Patients with HR-positive/HER2-negative ABC at Interim Analysis [ESMO] Improved progression-free survival seen in phase III, MONARCH 3 trial.
#ESMO17: Eli Lilly sets the stage for a CDK 4/6 showdown with Pfizer, Novartis — but not exactly to its advantage [EndPoints] Where it gets troublesome for Eli Lilly, though, is on the side effect data.
ESMO 2017: Strong Association Exists Between Tumour Type and Survival in Early Breast Cancer [ESMO] SToRM was planned to complement the SIGNAL/PHARE (NCT00381901/RECF1098) cohort of over 10,000 patients with early breast cancer, who are being followed through contact with their clinical team to capture information about their treatment and survival to gain information regarding the contribution of the patient’s genetic background to clinically relevant phenotypes in breast cancer metastasis.
ESMO 2017: Genomic Landscape of Patients with TNBC and Disease Recurrence Investigated [ESMO] NGS reveals potential genomic markers of recurrence in locally advanced TNBC.
ESMO 2017 Press Release: Abemaciclib Initial Therapy Improves Outcome in Endocrine-sensitive Advanced Breast Cancer [ESMO] The study (MONARCH 3) included 493 patients from 22 countries who had never been treated for metastatic disease. The primary endpoint was progression-free survival.
Lilly takes on Pfizer, Novartis with new breast cancer drug data [Reuters] Abemaciclib, like Pfizer’s Ibrance and Novartis’s Kisqali, belongs to a class of oral medicines called CDK 4/6 inhibitors that block cancer cells’ ability to divide and proliferate.
	5.6.7 ESMO - Immunothérapies
ESMO 2017: PD-L1 as a Prognostic Factor in Patients with Glioblastoma [ESMO] PD-L1 staining in patients’ samples may be prognostic of survival in glioblastoma.
ESMO 2017: Combined Nivolumab and Radiotherapy ± Temozolomide Is Safe in Patients With Newly Diagnosed Glioblastoma [ESMO] Updated safety results from CheckMate 143 support further study in patients with newly diagnosed glioblastoma.
ESMO 2017: First KEYNOTE-028 Report of Pembrolizumab Activity in Patients with PD-L1-positive pNETs and Carcinoid Tumours [ESMO] Some heavily-pretreated patients derive clinical benefit from single agent pembrolizumab treatment.
Cancer mutation gains ground as test for immunotherapy drugs [Reuters] Such analysis to measure what is known as tumor mutation burden (TMB) should lead to better targeting of medicines that have a typical list price of near $150,000 a year. It could also mean subgroups of patients with tumors where immunotherapy is not normally considered, like breast cancer, might get them.
	5.6.8 ESMO - Côlon-rectum
ESMO 2017: Location of the Primary Tumour, but not KRAS Mutations, May Indicate SIRT Survival Benefit in mCRC [ESMO] Addition of SIRT to FOLFOX +/- Bevacizumab did not improve OS or PFS overall in patients with mCRC and inoperable liver metastasis.
	5.6.9 ESMO - Col de l'utérus
Seattle Genetics Highlights Promising Data with Tisotumab Vedotin in Cervical Cancer at ESMO 2017 Congress [Seatlle Genetics] Response Rate of 32 Percent Among Patients with Relapsed, Recurrent and/or Metastatic Cervical Cancer.
ESMO 2017: Sub-study of the GAND-Emesis Trial with Neurokinin-1 Receptor Antagonist During Concomitant Chemoradiotherapy for Cervical Cancer [ESMO] Patients receiving fosaprepitant added to palonosetron and dexamethasone showed less impairment of daily functional life due to nausea.
ESMO 2017 Press Release: Study Confirms Chemoradiation is Best Treatment for Locally Advanced Cervical Cancer [ESMO] After a median follow-up of 58.5 months, the primary endpoint occurred in 30% of patients in the chemotherapy/surgery group and 23% of patients in the chemoradiation group.