In the control arm, the median age was also 68 years (IQR, 61-72) and 56% of patients were male.ĭata presented during the 18th Annual International Myeloma Workshop showed that at a median follow-up of 15.5 months with melflufen and 16.3 months with pomalidomide, the IRC-assessed PFS was 6.8 months (95% CI, 5.0-8.5) vs 4.9 months (95% CI, 4.2-5.7), respectively (HR, 0.79 95% CI, 0.64-0.98 P =. The median age in the investigative arm was 68 years (IQR, 60-72) and 57% were male. Key secondary end points comprised ORR, OS, and safety.
#IRC 61 TRIAL#
The primary end point of the trial was progression-free survival (PFS) per independent review committee (IRC) assessment and International Myeloma Working Group criteria.
#IRC 61 PLUS#
Study participants were randomized 1:1 to receive either intravenous melflufen at a dose of 40 mg on day 1 of each treatment cycle plus oral dexamethasone once weekly (n = 246), or 4 mg of pomalidomide on days 1 through 21 of each cycle plus 40 mg of oral dexamethasone once weekly (n = 249). Patients also needed to be refractory to lenalidomide and their last line of therapy. 4 To be eligible for enrollment, patients needed to be at least 18 years of age, have an ECOG performance status of 0 to 2, and have received 2 to 4 prior lines of therapy including lenalidomide (Revlimid) and a proteasome inhibitor. The open-label, phase 3 OCEAN trial enrolled a total of 495 patients relapsed/refractory multiple myeloma. We believe that this is the only viable path forward to accomplish this goal.” “The Company now needs to refocus its resources and energy on R&D and remain true to its mission of bringing hope to patients through science. Duvall, chief executive officer at Oncopeptides, stated in a press release. “The decision to withdraw from the market has been a difficult decision that has been made with great consideration and with the best intentions for patients and shareholders,” Marty J. Oncopeptides stated that they believe that the findings from the trial are “scientifically meaningful,” and they warrant further evaluation. During the dialogue, the regulatory agency expressed that it did not consider OCEAN to meet the criteria of a confirmatory trial. The global biotechnology company made the decision to withdraw the indication after speaking with the FDA. The median duration of response was 4.2 months (95% CI, 3.2-7.6).Įsuts from the confirmatory phase 3 OCEAN study (NCT03151811), which evaluated the safety and efficacy of melflufen and dexamethasone vs pomalidomide (Pomalyst) and dexamethasone in patients with relapsed/refractory disease and showed that the hazard ratio (HR) for overall survival (OS) in the intent-to-treat population was 1.104. 3 Of these patients, 14.4% achieved partial response and 9.3% experienced a very good partial response. The decision was based on findings from the phase 2 HORIZON trial (NCT02963493), which showed that the doublet elicited an overall response rate (ORR) of 23.7% (95% CI, 15.7%-33.4%) in the efficacy population (n = 97). In February 2021, the FDA approved melflufen plus dexamethasone for use in adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 CD38-directed monoclonal antibody. In addition, section 7701 contains over 50 definitions of terms that are used throughout the IRC.Oncopeptides AB (publ) has made the decision to withdraw the indication of melphalan flufenamide (Pepaxto melflufen) in combination with dexamethasone in select adult patients with relapsed or refractory multiple myeloma from the US market. Generally, each group of related sections will have a section of definitions. Partners and Partnerships (Partnership Tax) (sections 701 - 777)ĭefinitions. Income Tax on Estates and Trusts (sections 641 - 692) Therefore, it is often useful to read the table of contents to the IRC or to a subchapter in order to get an overview of the structure of a topic.Ĭommonly-Researched Subchapters of Subtitle A (Income Taxes): Aĭetermination of Tax Liability (sections 1 - 59B)Ĭomputation of Taxable Income (sections 61 - 291)Ĭorporate Distributions and Adjustments (Corporate Tax) (sections 301 - 385) Related sections are often cross-referenced to each other. The IRC is organized into subtitles, chapters, subchapters, and parts, each of which contains related provisions on a particular topic. Prior to the 1939 Code, federal tax laws were individual Revenue Acts.
#IRC 61 CODE#
The current version is the Internal Revenue Code of 1986, as amended. There have been three major enactments of the IRC: The 1939 Code, the 1954 Code, and the 1986 Code. This title is commonly referred to as the "Internal Revenue Code" (IRC) or sometimes simply as "The Code." Code contains nearly all of the federal tax laws.
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