Onco Actu du 14 mai 2020

	1. BIOLOGIE
Cancer cells deactivate their ‘Velcro’ to go on the attack [UC Louvain] UCLouvain researchers observed that certain cancer cells are, in fact, capable of decreasing the abundance of this ‘Velcro’ (CD166) on their surface. More specifically, these cells have found a way to reduce the adhesion of their surface by redirecting it into small internal vesicles: this is a mechanism called endocytosis.
	4.16 DÉP., DIAG. & PRONO. - PANCRÉAS
Diabetes type 3c is confirmed as an early manifestation of pancreatic cancer [CNIO] The team used data from more than 3,500 persons from PanGenEU, a large European study led by the researchers themselves, involving centres from six countries, including Spain, to analyse the relationship between multiple risk factors and pancreatic cancer.
	5.12.4 IMMUNOTHÉRAPIES - ESSAIS
New treatment extends lives of people with most common type of liver cancer [UCLA] Results from the clinical trial were published May 13 in the New England Journal of Medicine, and the drug combination (atezolizumab and bevacizumab) is currently being reviewed for approval under the U.S. Food and Drug Administration’s Real-Time Oncology Review pilot program.
	5.12.5 IMMUNOTHÉRAPIES - PHARMA
BCMA Delay: FDA Refuses Review of Bristol Drug, Asks for More Info [Xconomy] The Celgene acquisition was structured to pay its shareholders more if three of the company’s drugs win FDA approval. But this “contingent value right” will be paid only if all three pass regulatory muster.
Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma [BMS] Upon preliminary review, the FDA determined that the Chemistry, Manufacturing and Control (CMC) module of the BLA requires further detail to complete the review. No additional clinical or non-clinical data have been requested or are required. Bristol Myers Squibb is planning to resubmit the BLA no later than the end of July 2020.
Bristol Myers, bluebird to resubmit cancer therapy filing as FDA declines review [Reuters] Bristol Myers, which gained ide-cel through its $74 billion purchase of Celgene Corp, declined to give specific details on issues raised in the FDA’s “refusal to file” letter, saying it would look to expedite the agency’s decision by seeking a priority review label.
Bristol-Myers CVR Sinks After FDA Rejects Key Cancer Drug Filing [Bloomberg] The Refusal to File letter from the Food and Drug Administration deals a blow to an all-or-nothing $9 per share deal payment and casts more doubt on Bristol-Myers’s ability to meet the three requirements for the payout.
	5.2 PHARMA
Sanofi flashes more PhIII data on new multiple myeloma drug, setting up battle with Darzalex [EndPoints] In a 302-person Phase III trial, investigators combined the new drug, known as Sarclisa, with Amgen’s Kyprolis and showed that the cocktail was more effective than Kyprolis alone.
	5.5.1 ASCO (GÉNÉRAL)
Preview of Noteworthy Abstracts from the ASCO20 Virtual Scientific Program [OBR] The topics covered include smoking and lung cancer, maintenance therapy for ovarian cancer, the value of geriatric assessment, changes wrought by the Affordable Care Act, and videoconferencing for caregivers.
	5.5.1.1 ASCO (GÉNÉRAL) - INDUSTRIELS
Amgen Showcases Oncology Pipeline At ASCO 2020 [Amgen] Updated Data Evaluating Sotorasib (AMG 510), a First-in-Class Investigational KRASG12C Inhibitor, in Colorectal Cancer and Other Solid Tumors.
Bayer to Present Data from Growing Oncology Portfolio at the ASCO20 Virtual Scientific Program [Bayer] Data on final analysis of overall survival (OS) from the Phase III ARAMIS trial investigating darolutamide (Nubeqa™) in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
Lilly Oncology Showcases Innovation in Cancer Research at ASCO 2020 [Lilly] Latest Phase 1/2 LIBRETTO-001 registrational trial data examining Retevmo™ (selpercatinib) demonstrate commitment to advancing precision medicines for hard-to-treat tumor types.
AstraZeneca advances the science of cancer medicine with practice-changing data at the ASCO20 Virtual Scientific Program [AstraZeneca] Data to showcase unprecedented efficacy for Tagrisso in early-stage lung cancer and survival results for Imfinzi in small cell lung cancer .
	5.5.10 ASCO (HÉMATO)
J&J myeloma data heat up cell therapy battle [Biopharma Dive] Both ide-cel and JNJ-4528 work on the principle that T cells can be engineered to detect a distinctive protein on diseased cells in multiple myeloma, called B-cell maturation agent, or BCMA, and then destroy them.
Merck’s KEYTRUDA® (pembrolizumab) Superior to Brentuximab Vedotin (BV), a Standard of Care, in Patients With Classical Hodgkin Lymphoma (cHL) in Head-to-Head Phase 3 Trial [Merck] KEYNOTE-204 is the First Positive Phase 3 Trial of an Anti-PD-1 Therapy in Patients with Relapsed or Refractory cHL.
	5.5.13 ASCO (DIVERS)
Integrating Geriatric Assessment and Management Into Cancer Care Improves Quality of Life, Reduces Hospital Admissions for Older Patients [ASCO] First randomized trial of an intervention involving both geriatricians and oncologists in the care of older patients with cancer.
Quitting Smoking at Any Point, Even Close to a Lung Cancer Diagnosis, Improves Chances of Survival [ASCO] Former smokers who quit for less than 2 years before, between 2-5 years before, and for more than 5 years before a lung cancer diagnosis had, respectively, a 12%,16% and 20% reduced risk of death from all causes, when compared to current smokers.
	5.5.16 ASCO (MÉDECINE DE PRÉCISION)
Amgen researchers confirm the lackluster data on the KRAS G12C drug AMG 510 reported at ESMO — but they still have a long way to go exploring options [EndPoints] In their CodeBreak100 study, investigators reported on 25 patients with advanced tumors outside of both NSCLC and colorectal cancer. Among those, they tracked 22 patients for 7 weeks or longer and found 3 confirmed partial responses (1 appendiceal, 1 melanoma and 1 endometrial tumor). Thirteen had stable disease and the rest progressed.
MacroGenics chief Scott Koenig details the upbeat cancer drug data from 2 programs that drove a big spike in their share price [EndPoints] The surprise data that captured investors’ attention include the news that 43% — 6 of 14 — of patients with advanced HER2 tumors demonstrated an objective response to a combination of margetuximab and MGD013 with 4 confirmed responses and evidence of tumor shrinkage that could drive that response rate even higher.
	5.5.19 ASCO (REIN)
Merck’s Novel HIF-2α Inhibitor Showed an Objective Response Rate of Nearly 30% in Patients with von Hippel-Lindau (VHL) Disease-Associated Clear Cell Renal Cell Carcinoma [Merck] First-Time Data for MK-6482 Reinforce Innovative Science in Merck’s Expansive and Diverse Oncology Pipeline.
	5.5.2 ASCO (SEIN)
Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Demonstrated Statistically Significant Improvement in Progression-Free Survival Versus Chemotherapy in Certain Patients with Metastatic Triple-Negative Breast Cancer [Merck] Data from Pivotal Phase 3 Trial Showed KEYTRUDA Plus Chemotherapy Reduced the Risk of Disease Progression or Death by 35% Compared to Chemotherapy Alone as First-Line Treatment in Patients with Metastatic TNBC Whose Tumors Expressed PD-L1 (CPS ≥10).
	5.5.3 ASCO (PROSTATE)
ASCO: Pfizer, Astellas show Xtandi helps early prostate cancer patients live longer [Fierce Pharma] Patients lived a median 67 months on the Pfizer and Astellas drug, versus just 56.3 months on ADT plus placebo.
	5.5.4.2 ASCO (IMMUNOTHÉRAPIES-COMBINAISONS)
Exelixis Announces Results From COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab in Multiple Advanced Solid Tumor Types [Exelixis] Data from three cohorts of phase 1b COSMIC-021 trial to be presented.
	5.5.4.4 ASCO (IMMUNOTHÉRAPIES-POUMON)
New Combination Data for Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Clinical Benefit in Stage III Non-Small Cell Lung Cancer (NSCLC) and Reinforce Long-Term Survival in Metastatic NSCLC [Merck] First Combination Data in Stage III NSCLC from KEYNOTE-799 Showed KEYTRUDA Plus Concurrent Chemoradiation Achieved Objective Response Rate of 67.0% and 56.6% in Two Cohorts.
ASCO: Is the PD-1 target behind Keytruda's small-cell miss? Merck exec says no [Fierce Pharma] Back in January, Merck said Keytruda—its anti-PD-1 therapy—had missed the mark in an area where two of its rivals had succeeded. Both those rivals are anti-PD-L1 treatments, so could that PD-1/PD-L1 difference be the reason? The New Jersey drugmaker doesn’t think so.
Roche to present first clinical data on novel anti-TIGIT cancer immunotherapy tiragolumab at ASCO [Roche] Phase II CITYSCAPE trial shows promising results adding tiragolumab to Tecentriq in people with PD-L1-positive metastatic non-small cell lung cancer.
In race to lead the TIGIT pack in I/O, Roche delivers positive PhII data — but questions linger [EndPoints] Looking at the primary goal in non-small cell lung cancer, researchers reported that tiragolumab plus Tecentriq met both co-primary endpoints in the intent-to-treat population, showing a doubling of the objective response rate of the combo over Tecentriq alone: 31.3% versus 16.2%.
Three-Year Data from CheckMate -227 Confirm Durable, Long-Term Survival Benefit for Opdivo (nivolumab) Plus Yervoy (ipilimumab) vs. Chemotherapy in Metastatic First-Line Non-Small Cell Lung Cancer Patients with PD-L1 ≥1% [BMS] Duration of response with Opdivo plus Yervoy was more than three times longer than with chemotherapy across PD-L1 expression levels (<1% or ≥1%).
Bristol Myers Squibb spells out OS benefit of Opdivo/Yervoy combo plus 'limited' chemotherapy — is it enough to change practice? [EndPoints] Whether the clinical benefit is sufficient to make it a valuable option remains to be seen, as adding chemo to two drugs with known toxicity issues only complicates the safety profile.
Opdivo (nivolumab) Plus Yervoy (ipilimumab) with Limited Chemotherapy Significantly Improves Overall Survival vs. Chemotherapy Alone for Patients with First-Line Metastatic Non-Small Cell Lung Cancer in CheckMate -9LA Study [BMS] Opdivo plus Yervoy given concomitantly with two cycles of chemotherapy demonstrated prolonged overall survival at an interim analysis, with sustained improvement in a subsequent analysis with a minimum follow-up of one year.
	5.5.4.5 ASCO (IMMUNOTHÉRAPIES-CAR-T, THÉRAPIES CELLULAIRES)
Allogene gives first look at an 'off the shelf' cell therapy for lymphoma [Biopharma Dive] The results announced Wednesday come from a study of patients with either follicular lymphoma or large B-cell lymphoma — two forms of NHL — and had failed at least two prior treatments.
Allogene spotlights their off-the-shelf CAR-T contender ‘501 with a snapshot on CRs and no GVHD [EndPoints] Bottom line: Out of 11 evaluable patients, researchers working on R&D chief Rafael Amado’s team tracked an impressive 78% response rate, with 3 of the patients recording a complete response and 4 others demonstrating a partial response.
Bristol Myers Squibb and bluebird bio to Present Updated Positive Results from Pivotal KarMMa Study of Ide-cel in Relapsed and Refractory Multiple Myeloma Patients at ASCO20 [BMS] Ide-cel, an investigational CAR T cell therapy for multiple myeloma, met primary endpoint and key secondary endpoints.
	5.5.7 ASCO (GYNÉCO)
Maintenance Therapy With PARP Inhibitor Olaparib Extends Survival By Over 1 Year in Patients With Relapsed Ovarian Cancer and BRCA Mutation [ASCO] Maintenance therapy with olaparib (Lynparza) extended overall survival by nearly 13 months (12.9) compared with placebo in women with platinum-sensitive relapsed ovarian cancer with BRCA 1 or 2 mutations, in a randomized phase III trial.
	5.5.8 ASCO (POUMON)
ASCO: Roche's Alecensa stays on top of Xalkori with long-term survival showing [Fierce Pharma] At the five-year mark, 62.5% of previously untreated patients taking Alecensa were still alive, versus just 45.5% of the Xalkori group.
Days after rapid FDA approval, Lilly and Blueprint go head-to-head again at ASCO [EndPoints] In a pair of ASCO abstracts, both Lilly and Blueprint once again showed off positive data from their RET-inhibitors, setting up what could be a dual market for years to come.
	6.15 LUTTE CONTRE LES CANCERS - COVID-19
COVID-19 in Children With Cancer in New York City [JAMA Oncology] This report suggests that pediatric patients with cancer may not be more vulnerable than other children to infection or morbidity resulting from SARS-CoV-2.