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Replies to post #212685 on Biotech Values
07/27/17 7:39 AM
07/27/17 9:20 AM
JULY 27, 2017
Collaboration Aims to Maximize the Potential of PARP and MEK Inhibitors in Combination with PD-L1/PD-1 Medicines, Based on Growing Scientific Evidence That These Combinations Offer New Potential for the Treatment of a Range of Tumor Types
AstraZeneca and Merck Will Independently Develop and Commercialize LYNPARZA and Potential Medicine Selumetinib in Combinations with Companies’ Respective PD-L1/PD-1 Immuno-Oncology Medicines IMFINZI and KEYTRUDA
Collaboration Will Significantly Expand the Potential of LYNPARZA, the World’s First and Leading PARP Inhibitor, as a Monotherapy and as a Backbone of Combination Treatments for Multiple Cancer Types; Agreement Also Includes AstraZeneca’s Selumetinib, a MEK inhibitor
The Companies Will Share Development and Marketing Costs Equally, as well as Gross Profits from LYNPARZA and Selumetinib Financial considerations
Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialization costs for LYNPARZA and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities. Gross profits from LYNPARZA and selumetinib product sales generated through monotherapies or combination therapies will be shared equally.
Merck will fund all development and commercialization costs of KEYTRUDA in combination with LYNPARZA or selumetinib. AstraZeneca will fund all development and commercialization costs of IMFINZI in combination with LYNPARZA or selumetinib.
AstraZeneca will continue to manufacture LYNPARZA and selumetinib.
As part of the agreement, Merck will pay AstraZeneca up to $8.5 billion in total consideration, including $1.6 billion upfront, $750 million for certain license options and up to an additional $6.15 billion contingent upon successful achievement of future regulatory and sales milestones.
Merck expects to book its share of product sales of LYNPARZA and selumetinib, net of commercialization costs, as Alliance Revenue and its share of development costs associated with the collaboration as part of its Research & Development expense.
07/27/17 2:30 PM
08/12/17 6:53 PM
04/24/18 9:48 AM
AstraZeneca…today announced high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments. This randomised, open-label, multi-centre trial assessed the efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab, as well as Imfinzi and tremelimumab monotherapies, versus standard-of-care chemotherapy (SoC) in patients with PDL1-low/negative NSCLC (sub-study B), and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A).
In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to SoC. Activity and safety of monotherapy arms of sub-study B were consistent with prior published data.
Sub-study A was not powered for statistical significance; however, Imfinzi monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy.
11/16/18 10:11 AM
AstraZeneca…today announced final overall survival (OS) results for the Phase III MYSTIC trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) monotherapy and the combination of Imfinzi and tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).
In the primary analysis population of patients, whose tumours express PD-L1 on 25% or more of their cancer cells as determined by the VENTANA PD-L1 (SP263) Assay, Imfinzi monotherapy and the combination of Imfinzi plus tremelimumab did not meet the primary endpoints of improving OS compared to SoC chemotherapy. While the OS result did not meet statistical significance, a hazard ratio (HR) of 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) was observed with Imfinzi monotherapy. The combination therapy had an HR of 0.85 (98.77% CI 0.611-1.173; nominal p=0.202); the data support further analysis in exploratory subgroups.
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