Independent central review of clinical imaging remains the standard for oncology clinical trials with registration potential. A limited independent central review strategy has been proposed for solid tumor trials based on concordance between central and local evaluation of response. Concordance between independent central review and local evaluation of response in hematological malignancies is not known.
We retrospectively evaluated concordance between prospectively performed central and local assessments of response using the Revised Response Criteria for Malignant Lymphoma across two international, open-label, single-arm, registration studies of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma (N = 102) or systemic anaplastic large-cell lymphoma (N = 58).
Overall objective response rates were similar between assessors for both the trial in Hodgkin lymphoma (75% independent central review, 72% local evaluation) and the trial in anaplastic large-cell lymphoma (86% independent central review, 83% local evaluation). Patient-specific objective response concordance was also substantial (Hodgkin lymphoma: kappa = 0.68; anaplastic large-cell lymphoma: kappa = 0.74). Median progression-free survival was similar between assessors for patients with anaplastic large-cell lymphoma (14.3 months by independent central review (95% confidence interval: 6.9, -); 14.5 months by local evaluation (95% confidence interval: 9.4, -)), but longer by local evaluation in patients with Hodgkin lymphoma (5.8 months by independent central review (95% confidence interval: 5.0, 9.0); 9.0 months by local evaluation (95% confidence interval: 7.1, 12.0)). Median duration of response was longer by local evaluation in both malignancies, which was primarily attributable to earlier computed tomography and positron emission tomography-based scoring of progression by independent central review.
A limited independent review audit strategy for clinical trials of some lymphomas appears feasible and practical based on substantial concordance in assessments of overall objective response by central and local evaluation in two international, prospective, registration trials in lymphoma. Some variability between assessors in the time-to-event endpoints was observed, which appeared attributable to earlier assignments of progression by independent central review compared with local evaluation.
© The Author(s) 2016.

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Sunitinib is a multi-targeted tyrosine kinase inhibitor used in the treatment of advanced renal cell carcinoma (RCC) and imatinib-resistant/intolerant gastrointestinal stromal tumors (GIST).
A meta-analysis of 10 prospective clinical studies in advanced RCC and GIST was performed to support the development of pharmacokinetic (PK) and PK/pharmacodynamic (PD) models that account for the effects of important covariates. These models were used to make predictions with respect to the PK, safety, and efficacy of sunitinib when administered on the traditional 4-weeks-on/2-weeks-off schedule (Schedule 4/2) versus an alternative schedule of 2 weeks on/1 week off (Schedule 2/1).
The covariates found to have a significant effect on one or more of the PK or PD parameter studies included, age, sex, body weight, race, baseline Eastern Cooperative Oncology Group performance status, tumor type, and dosing schedule. The models predicted that, in both RCC and GIST patients, Schedule 2/1 would have comparable efficacy to Schedule 4/2, despite some differences in PK profiles. The models also predicted that, in both indications, sunitinib-related thrombocytopenia would be less severe when sunitinib was administered on Schedule 2/1 dosing compared with Schedule 4/2.
These findings support the use of sunitinib on Schedule 2/1 as a potential alternative to Schedule 4/2 because it allows for the management of toxicity without loss of efficacy.

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Busulfan (Bu)-containing regimens are commonly used in myeloablative regimens prior to allogeneic hematopoietic cell transplantation (HCT). Yet, there is considerable variability on how Bu is administered related to frequency (four times a day, Q6 or daily, Q24) and the combination with other chemotherapeutic agents (cyclophosphamide, Cy or fludarabine, Flu). A prospective cohort study of recipients of Bu-based conditioning according to contemporary practices was used to compare different approaches in using Bu (BuCy Q6 N=495; BuFlu Q24 N=331; BuCy Q24 N=96; BuFlu Q6 N=91) in patients with myeloid malignancies from 2009 to 2011. BuFlu Q24 recipients were more likely to be older and tended to have worse performance status and higher comorbid burden. The cumulative incidence of hepatic veno-occlusive disease (p=0.4), idiopathic pneumonia (p=0.5) and seizures (p=0.5) did not differ across groups. One-year HCT related mortality ranged from 12% to 16% (P=0.8), three-year relapse incidences ranged from 32% to 36% (p=0.8) and three-year overall survival ranged from 51% to 58% (p=0.2) across groups. This study demonstrates that the use of intravenous Bu Q6 or Q24 or accompanied by Cy or Flu have similar outcomes in the myeloablative setting for treatment of myeloid malignancies.
Copyright © 2016 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

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On May 6, 2016 Oxford BioMedica plc ("Oxford BioMedica" or "the Company") (LSE:OXB), a leading gene and cell therapy company, reported that new data has been presented from two clinical studies indicating ground-breaking long-term four-year sustained and, in one of the studies, dose-dependent gene expression with the Company’s LentiVector delivery platform (Press release, Oxford BioMedica, MAY 6, 2016, View Source [SID:1234512034]).

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On 5 May 2016, Professor Stéphane Palfi presented a poster on OXB-101, a gene therapy product for the treatment of Parkinson’s disease (PD), at the 19th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Washington DC, USA. In the Phase I/II study 15 advanced PD patients were treated with OXB-101 in three dose cohorts. OXB-101 demonstrated a favourable safety profile and a statistically significant improvement in motor function relative to baseline at six and 12 months post-treatment. The most recent follow-up data, presented this week, shows that the majority of patients continue to experience improvement in motor function relative to baseline over the four years since treatment. The Company has since developed OXB-102, a more potent version of OXB-101, and is planning to start a Phase I/II study in mid-2016. OXB-102 is Oxford BioMedica’s gene therapy product that utilises its proprietary LentiVector delivery platform to transfer three genes for dopamine synthesis in the striatum.

In addition, on 4 May 2016, Dr Andreas Lauer gave an oral presentation on Oxford BioMedica’s LentiVector-based treatment for neovascular age-related macular degeneration (wet AMD), at the Association for Research in Vision and Ophthalmology (ARVO) conference in Seattle, USA. Consistent with results previously announced at the ARVO conference, the new data presented demonstrates that LentiVector gene expression was dose-dependent and continued without significant decline for more than four years.

Commenting on the new emerging data, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "We are very encouraged by the demonstration of long term expression and clinical benefit in patients indicated by the four-year follow-up data from these two clinical studies. We believe this is the first time gene therapy products have been directly measured in the eye and the longevity in both expression and efficacy to date reinforces the benefits of the Company’s pioneering LentiVector gene delivery platform in the treatment of chronic conditions."

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On May 6, 2016 PharMerica Corporation (NYSE:PMC), a national provider of institutional, specialty home infusion, hospital and oncology pharmacy services, reported its financial results for the first quarter ended March 31, 2016 (Press release, PharMerica, MAY 6, 2016, View Source;p=RssLanding&cat=news&id=2166002 [SID:1234512064]).

1Q’16 Results
Comparison to
1Q’15

Comparison to
4Q’15
Revenue $524.5 million Increase of 2.5% Increase of 0.7%
Adjusted EBITDA $30.3 million Decrease of 14.4% Decrease of 12.7%
Adjusted diluted earnings per share
$0.45 Decrease of 21.1% Decrease of 19.6%
Gross profit $82.0 million Decrease of 7.4% Decrease of 5.4%
Selling, general and administrative $57.0 million Decrease of 3.4% Increase of 2.9%
Generic drug dispensing rate
86.6% Increase of 130 basis points Increase of 30 basis points

Greg Weishar, PharMerica Corporation’s Chief Executive Officer, said, "PharMerica’s first quarter 2016 exceeded our expectations. We believe we are well positioned to deliver on our 2016 financial objectives while driving continued growth and shareholder value creation.

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"Prescriptions dispensed in the first quarter of 2016 were 8.6 million as compared to 8.4 million in the fourth quarter of 2015 and 8.2 million in the third quarter of 2015. This quarter represents the second sequential quarterly increase in prescription volume. In addition, we continue to improve the generic drug dispensing rate; this quarter’s rate of 86.6% represents a 130 basis point increase versus the first quarter of 2015. We expect the generic dispensing rate to further improve as brand patent expirations occur throughout this year and beyond.

"Also, we continue to make progress with respect to the diversification program. Specialty home infusion, oncology and hospital pharmacy management revenues grew 47% on a year over year basis. We achieved revenue growth both organically and through acquisitions. Importantly, EBITDA is growing faster than revenues as higher prescription volumes drive operating leverage. We are confident diversified revenues will exceed $700 million in 2017, and the diversification program will meaningfully contribute to the Company’s overall EBITDA growth over the next several years.

Mr. Weishar concluded, "In summary, we are off to a good start in 2016, and we will continue to pursue attractive acquisitions that drive share and scale. We remain optimistic about the Company’s long-term prospects, and we are well positioned to return to strong growth in 2017 and beyond."

Full Year 2016 Financial Guidance

PharMerica reaffirms its full year 2016 guidance metrics:

Revenue in the range of $2.125 billion to $2.150 billion;
Adjusted EBITDA in the range of $130.3 million to $135.3 million; and
Adjusted diluted earnings per share in the range of $1.95 to $2.05.
The Company notes that its 2016 guidance does not include the effect of any future 2016 acquisitions.

First Quarter 2016 Results

The results for the first quarter 2016 are set forth below:

Key Comparisons of First Quarters Ended March 31, 2016 and 2015:
Revenues for the first quarter of 2016 were $524.5 million compared with $511.6 million for the first quarter of 2015, an increase of 2.5%. The increase in revenues of $12.9 million is due to significant organic growth and acquisitions in the Company’s specialty businesses, partially offset by the 2015 initiative to improve the overall quality mix of clients, the 2016 reduction in Medicare Part D reimbursement and 2015 brand to generic conversions.

Gross profit for the first quarter of 2016 was $82.0 million compared with $88.6 million in the first quarter of 2015; a decrease of 7.4%. The decrease in gross profit was driven by higher drug costs under the Cardinal Health prime vendor agreement, changes made in 2015 to improve the overall quality mix of clients and lower Medicare Part D reimbursement.

Selling, general and administrative expenses were $57.0 million or 10.9% of revenues for the three months ended March 31, 2016 compared to $59.0 million or 11.5% of revenues for the three months ended March 31, 2015. The decrease of $2.0 million was due to cost improvements and lower bad debt expense.
Adjusted EBITDA for the first quarter of 2016 was $30.3 million compared with $35.4 million in the first quarter of 2015; a decrease of 14.4%.

Net income for the first quarter of 2016 was $4.1 million, or $0.13 diluted earnings per share, compared to $9.6 million, or $0.31 diluted earnings per share, for the same period in 2015. Adjusted diluted earnings per share was $0.45 in the first quarter of 2016 compared to $0.57 in the first quarter of 2015.

Cash flows provided by operating activities for the first quarter of 2016 were $62.3 million compared with $44.3 million in the first quarter of 2015. The increase in cash from operating activities is due to a decrease in inventory purchases and a higher accounts payable balance due to the timing of the weekly Cardinal Health prime vendor payment. Additionally, in the first quarter of 2015, $48.8 million of AmerisourceBergen drug purchase payments were withheld.