AAC Whitehead hard white spring wheat

AAC Whitehead, an awned hard white spring wheat (Triticum aestivum L.) cultivar, combines high grain yield and good agronomic characteristics with excellent disease resistance. Based on 34 station-years of registration trial data from 2017 to 2019, AAC Whitehead had grain yield significantly higher than all of the check cultivars. AAC Whitehead had maturity similar to the checks, low lodging scores, and significantly shorter plant height than Snowstar and Whitehawk. AAC Whitehead had significantly lower test weight and higher kernel mass than than all the check cultivars. AAC Whitehead expressed resistance to the prevalent races of leaf, stripe and stem rust, and common bunt; and moderate resistance to Fusarium head blight (FHB). It also expressed tolerance to the orange wheat blossom midge. AAC Whitehead expresses quality attributes within the range of the check cultivars and is eligible for grades of Canada Western Hard White Spring wheat.

AAC Awesome special purpose spring wheat

AAC Awesome is a high yielding spring wheat (Triticum aestivum L.) cultivar eligible for the Canada Western Special Purpose (CWSP) wheat class. Based on 29 site-years of testing over 3 years in the General Purpose Wheat Registration trial (2013–2015), AAC Awesome yielded 14% more grain than AC Andrew, and surpassed yields of Sadash, 5702PR, and Pasteur by 12%, 22%, and 9%, respectively. AAC Awesome had similar maturity, was slightly taller, had higher test weight and larger kernels as compared to AC Andrew. AAC Awesome had excellent levels of resistance to the prevalent races of leaf, stem and stripe rust. It expressed an intermediate level of resistance to Fusarium head blight (FHB), common bunt and loose smut. It also expressed tolerance to the orange wheat blossom midge. AAC Awesome is eligible for grades of Canada Western Special Purpose Wheat class.

AAC Perform red spring wheat

AAC Perform, an awned hard red spring wheat (Triticum aestivum L.) cultivar, combines high grain yield and good agronomic characteristics with excellent resistance to leaf, stem, and stripe rust. Based on 43 station years of registration trial data from 2017 to 2019, the grain yield of AAC Perform was about 6% higher than AAC Foray and about 12% over AAC Penhold. AAC Perform was significantly shorter than AAC Foray and had straw strength similar to AAC Penhold. It was about two days later maturing than AAC Foray. AAC Perform had similar test weight, smaller kernel size and lower protein concentration as compared with AAC Foray. AAC Perform had milling and baking quality suitable for grades of the Canada Prairie Spring Red wheat market class.

Evaluation of barley testing locations in Ontario

In order to develop new barley cultivars, promising genotypes are evaluated for their performance each year at a number of test locations representing the target region. In this study, we analyzed the Ontario barley registration trial data from 2015 to 2020 to understand the barley mega-environment in Ontario and to evaluate the suitability of the test locations. The analysis showed that the barley test locations fall into two mega-environments, with a major mega-environment consists of five test locations and a minor mega-environment with a single test location. Among the six test locations used for the barley registration trials, Palmerston was found to be the most desirable for the barley cultivar evaluation representing the Ontario barley growing region. This study also identified OB2930-35, a recently released cultivar, to be both high yielding and stable across Ontario. These findings are useful for future barley breeding and cultivar evaluation in Ontario.

Racial diversity and reporting in FDA registration trials for genitourinary (GU) cancers from 2006-20.

22 Background: GU cancers account for 1 in 5 of new cancer diagnoses in the USA. Significant racial disparities exist in terms of incidence, treatment and outcomes. Current FDA clinical trial guidance advises race reporting as a minimum of 5 categories (White/Caucasian, Black, Asian, American Indian or Alaskan Native [AIAN] and Native Hawaiian or Pacific Islander [NHPI]). Guidelines from the International Committee of Medical Journal Editors (ICMJE) recommend that authors should as a minimum, provide descriptive data for variables such as race and ethnicity. We analysed racial diversity in GU registration trials and compliance with FDA/ICMJE guidance in reporting. Methods: A retrospective review of new market authorisations in GU cancers from Jan 2006 to Oct 2020 was conducted utilizing the FDA website. Clinical trials cited on the licensing label for market authorization were recorded and corresponding registration trial publication identified. If race was unreported or partially reported (defined ≤3 groups), then the trial report on clinicaltrials.gov or FDA website was analysed. Total proportion of racial group participation and the proportion of registration trials with adequate reporting was determined. Results: We identified 42 new licensing indications, involving 33 unique drugs. Overall 30,316 patients participated in GU cancer registration trials; 21,068 (69.5%) White or Caucasian, 2516 (8.3%) Asian, 621(2%) Black or African American, 92 (0.3%) AIAN, 17 (0.1%) NHPI, 558 (1.8%) other or multiple races and 5463 (18%) unknown. Table shows breakdown by tumour group. Race reporting occurred in 23 (55%) registration trial publications, of which 5 provided only limited information (e.g. Caucasian only). For studies where no race information was reported, a further 10 (24%) had information within the trial report. In the 5 years prior to the introduction of FDA guidance in 2016 only 30% of registration studies met FDA/ICJME requirements. Since 2016 this has improved significantly to 60%. Conclusions: Despite the higher incidence of GU cancers in non-white populations, this study has revealed the relative over-representation of white participants in GU registration trials. The inclusion of black trial participants is in particular disproportionately low when compared to the burden of disease in this population group. Recruitment of black and other minority participants should be a research priority. [Table: see text]

Safety Profile of Idelalisib in Patients with Refractory Follicular Lymphoma: Interim Analysis of a Noninterventional Study

Introduction: Idelalisib, a selective oral inhibitor of PI3Kδ, was approved by the FDA and EMA as monotherapy for patients with advanced follicular lymphoma (FL) based on positive efficacy and safety results from the registration phase 2 trial in patients with indolent non-Hodgkin lymphoma (iNHL) refractory to 2 prior regimens (NCT01282424; 101-09). Phase 3 studies of idelalisib in earlier lines of treatment for iNHL were terminated prematurely due to an increased risk of death and higher incidence of serious adverse events (AEs) associated with idelalisib. Herein, we present the preplanned interim results as of June 8, 2020, of the safety of idelalisib monotherapy in patients with refractory FL treated in the EU from one of the largest noninterventional trials of idelalisib. Methods: This was a noninterventional, partially retrospective cohort study conducted in 10 European countries (EUPAS19618; NCT03568929). Eligible patients were adults aged ≥18 years treated with idelalisib for refractory FL, per the Summary of Product Characteristics and treatment guidelines, in routine clinical practice. Data was collected from patients' medical records and anonymized. Safety events were evaluated and included treatment-emergent AEs (TEAEs), health outcomes of interest (HOIs) requested by the EMA (bowel perforations, Grade ≥3 diarrhea/colitis, progressive multifocal leukoencephalopathy, pneumonitis, Grade ≥3 rash, infections, Stevens-Johnson syndrome, transaminase elevations, and hepatocellular injury), and deaths. TEAEs were defined as AEs that occurred between first dose and 30 days after last dose. Data were summarized using descriptive statistics. Rates per person-year were calculated as the number of patients experiencing an AE divided by the person-time at risk. Results: For the 158 patients included in this analysis, median age was 67 years and 84 (53%) were male. A summary of patient and disease characteristics at baseline are presented in Table 1. At treatment initiation, 47 (30%) patients had grade 2 FL and 105 (66%) had Ann Arbor stage III/IV disease, though these characteristics were not captured for 42% and 20% of patients, respectively; 149 (94%) had ≥2 prior therapies. The median duration of idelalisib exposure was 165 (range 11-1321) days, and patients were observed for a median of 323 (range 12-1676) days. In total, 144 (91%) patients experienced a TEAE, with a rate of 3.36 per person-year. The proportion of patients experiencing Grade 3/4, severe, common, and HOI TEAEs are presented in Table 2. Diarrhea of any grade was the most common TEAE, and infections were the most common treatment-emergent HOI. During the TEAE period, 19 (12%) patients died (Table 2). The proportion of common TEAEs reported in this analysis were lower compared with a subgroup analysis of patients with FL from the registration trial (Salles Haematologica 2017; DOI: 10.3324/haematol.2016.151738), including diarrhea 27% vs 51%, cough 9% vs 32%, fever/pyrexia 10% vs 29%, pneumonia 5% vs 11%; treatment-emergent Grade 3/4 diarrhea/colitis and transaminase elevations were also lower in this analysis: 8% vs 17% and 4% vs 14%. This comparison is limited due to differences in study populations, namely that patients in the registration trial had more advanced disease (stage III/IV, 66% vs 83%) and had a higher median number of prior therapies (3 vs 4). Conclusions: This interim analysis of the safety of idelalisib in patients with refractory FL in this large noninterventional safety study provides an estimate of potential final study findings. The AE profile from this study appears to corroborate the known safety profile of idelalisib. No new safety signals were detected. Disclosures Salles: Bristol Myers Squibb: Consultancy, Other; Genmab: Consultancy; Gilead: Consultancy, Honoraria, Other: Participation in educational events; Epizyme: Consultancy; Abbvie: Consultancy, Honoraria, Other: Participation in educational events; Autolus: Consultancy; Amgen: Honoraria, Other: Participation in educational events; Celgene: Consultancy, Honoraria, Other: Participation in educational events; Debiopharm: Consultancy; Takeda: Consultancy, Honoraria, Other; Novartis: Consultancy, Honoraria, Other; F. Hoffman-La Roche Ltd: Consultancy, Honoraria, Other; Janssen: Consultancy, Honoraria, Other: Participation in educational events; Karyopharm: Consultancy; Kite: Consultancy, Honoraria, Other; MorphoSys: Consultancy, Honoraria, Other. Pettengell:Celgene: Honoraria; MEI Pharma: Honoraria; Roche Ltd: Honoraria; Takeda: Honoraria. Vandenberghe:Celgene: Other: sponsorship to attend Lugano lymphoma meeting in 2019; Abbvie: Other: travel grants, Research Funding; Gilead: Other: travel grants, Research Funding; Janssen: Other: travel grants; Roche: Other: travel grants, Research Funding. Corradini:Kiowakirin: Consultancy, Honoraria; Incyte: Consultancy; Gilead: Consultancy, Honoraria, Other; F. Hoffman-La Roche Ltd: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Other; BMS: Other; Servier: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Janssen: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Other; Kite: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Other; Takeda: Consultancy, Honoraria, Other; AbbVie: Consultancy, Honoraria, Other. De Belder:Gilead Sciences Europe, Ltd.: Current Employment. Shah Gupta:Gilead Sciences, Ltd.: Current Employment. van Troostenburg:Gilead Sciences GmbH: Current Employment. Rajakumaraswamy:Gilead Sciences, Inc.: Current Employment. Ramroth:Gilead Sciences, Ltd.: Current Employment.