AbbVie axes multi-billion cancer flop Rova-T after another trial fails

pharmaphorum | August 29, 2019

AbbVie axes multi-billion cancer flop Rova-T after another trial fails
AbbVie has axed its troubled lung cancer drug Rova-T, after another trial failure from the drug that is turning out to be an expensive flop, costing almost $10 billion so far. As it searched for new drugs to replace revenues lost from the patent expiry of its mega-blockbuster Humira, AbbVie snapped up Rova-T’s developer Stemcentrx in 2016 for $5.8 billion. But the gamble has not paid off after yet another trial disaster from the antibody-drug conjugate, full name rovalpituzumab tesirine. AbbVie already took an impairment charge of $4 billion earlier this year following a previous Rova-T trial failure, and there are doubts about the other compounds that AbbVie added to its pipeline following the Stemcentrx deal. The idea behind Rova-T is to use the antibody to target delta-like protein 3 (DLL3), an antigen expressed in more than 80% of small cell lung cancer tumours, prevalent in tumour cells and cancer stem cells but not healthy tissue. Then the cytotoxic agent tesirine could be delivered directly to the DLL-3 expressing cancer cells. It sounds great in theory but in practice it’s not working – AbbVie announced that it has ended the phase 3 MERU trial of Rova-T as first line maintenance therapy in advanced small-cell lung cancer (SCLC) after it demonstrated no survival benefit in a pre-planned interim analysis comparing it with placebo. The company made the decision based on a recommendation from the trial’s Independent Data Monitoring Committee, which cited a lack of survival benefit compared with placebo.

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Xeris Pharmaceuticals Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)

Xeris Pharmaceuticals, Inc. | September 01, 2021

Xeris Pharmaceuticals, Inc., a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that the company has completed enrollment and successfully dosed all participants in a Phase 1 study of levothyroxine (XP-8121) to evaluate the pharmacokinetics, safety and tolerability, and potential for weekly dosing of the investigational, novel, subcutaneous (SC) injection for the treatment of hypothyroidism. XP-8121 is a novel formulation that could potentially mitigate many of the challenges associated with oral formulations, such as identification of an ideal dose due to absorption variation and medication adherence for patients who have difficulty maintaining a stable, therapeutic serum level. Preclinical studies of SC XP-8121 showed a sustained plasma exposure profile and similar maximum plasma concentration (Cmax) when compared with equivalent doses of the oral formulation. The Phase 1 clinical study of levothyroxine (XP-8121) is a single ascending dose crossover design in 30 healthy participants to compare matching doses of oral levothyroxine (Synthroid®) and subcutaneous (SC) XP-8121. The primary endpoints of the study are to characterize the absorption and elimination kinetics of XP-8121 and compare bioavailability of XP-8121 to oral levothyroxine. Secondary endpoints are safety and tolerability of XP-8121. The study is being conducted in partnership with Dr. Danielle Armas and Celerion, a leading contract research organization with extensive experience performing first-in-human studies. “The potential for a once weekly subcutaneous injection of levothyroxine would represent a promising novel approach in treating patients with hypothyroidism. Drug non-compliance, resistant hypothyroidism, and limited GI absorption are some of the major reasons for treatment failure or suboptimal treatment with oral levothyroxine. These challenges could be mitigated by XP-8121 and translate into the long-term health benefit of achieving a euthyroid state for patients,” said Dr. Armas, Senior Principal Investigator, Celerion. “Because our levothyroxine formulation enables a small volume SC injection, as an injectable maintenance therapy, it may facilitate less frequent dosing. This may provide clinical advantages over the established oral daily route, by providing predictable bioavailability, comparable safety, and ease of use,” said Dr. Ken Johnson, Xeris’ Senior Vice President of Global Development and Medical Affairs. About Levothyroxine and Hypothyroidism. The thyroid gland is responsible for the synthesis, storage, and release of metabolic hormones including thyroxine (T4) and triiodothyronine (T3) [Colucci et al, 2013]. These hormones are crucial in the regulation of critical metabolic processes and are vital for normal growth and development during fetal life, infancy, and childhood. Therapeutically, levothyroxine is administered when the body is deficient in the endogenous hormone. The goal of therapy is restoration of the euthyroid state which can reverse the clinical manifestations of hypothyroidism and significantly improve quality of life [Winther et al, 2016]. The treatment of choice for correction of hypothyroidism is levothyroxine, which is the mainstay of thyroid hormone replacement therapy. It is one of the most widely prescribed drug products in the United States, but the complexity of maintaining biochemical and clinical euthyroidism in patients undergoing treatment with oral levothyroxine cannot be underestimated. It has been reported that nearly 40% of patients undergoing treatment with oral levothyroxine are either over- or under-treated [Laurent et al, 2018] due to factors that include, but are not limited to, drug formulation, use of the drug with food, adherence to the drug, use of concomitant medications, and pre-existing medical conditions. Many patients failing to reach target TSH levels are generally managed by simply increasing their levothyroxine daily dose [Chiovato et al, 2019]. However, levothyroxine is a drug with a narrow therapeutic index [Vita et al, 2014], meaning that relatively small deviations from the proper dose can cause a clinically meaningful shift in pharmacological effects when administered to a patient; thus, the titration of levothyroxine oral drug may be a tailored and incremental process. About Xeris Pharmaceuticals, Inc. Xeris is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable drug, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system. Xeris is headquartered in Chicago, IL.

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Prnewswire | May 27, 2020

Rx Savings Solutions announced today its entrance into the mid-market segment with the expansion of their personalized prescription drug transparency program to midsize organizations. With this comprehensive solution driven by more than 29,000 clinical recommendations, more benefit leaders of all sizes can provide a valuable resource for members to engage with personalized savings options. As pharmacy continues to be the most predictable and repeated spend in healthcare, Rx Savings Solutions aims to empower more members and clients with the necessary information to navigate their pharmacy options. Combining a patented clinical suggestions engine with a proven member engagement and concierge support model, the MidMarket offering is a turnkey approach to helping members and plans reduce their pharmacy spend.

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USANA launches new, cutting-edge Mood and Relaxation product line at Americas and Europe Virtual Convention

Prnewswire | August 18, 2020

Managing occasional stress and keeping a calm mind are vital for navigating today's world. And USANA's new Mood and Relaxation product line is designed to help. The company's annual Americas and Europe Convention went virtual this year, and USANA continued to impress with the launch of its new Stress Relief mood-support supplement and Calm Response essential oil balm. These products take a natural and mindful approach to overall health and well-being.* To find out more about USANA and its new Mood and Relaxation product line, please visit usana.com. "The launch of our new product line marks a pivotal moment in USANA's history," says Dan Macuga, USANA's chief communications and marketing officer. "We are expanding our reach into a new market space, and the quality of our new products prove it's a space we belong. Day-to-day stressors and obstacles can be overwhelming, and I'm proud USANA has formulated products to help our customers maintain positive emotional health."

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Spotlight

A biosimilar co-developed by generics giant Mylan and Indian biopharmaceutical company Biocon (NSE: BIOCON) is as effective in treating HER2 metastatic breast cancer as Herceptin (trastuzumab), according to the results of a Phase III clinical trial.