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Friday, June 12, 2020

AbbVie reports additional data from successful study of Skyrizi in psoriasis

Following up on its initial announcement in January, AbbVie (ABBV +0.1%) announces additional data from a Phase 3 clinical trial, IMMerge, comparing Skyrizi (risankizumab-rzaa) to Novartis’ (NVS -0.3%) Cosentyx (secukinumab) in patients with moderate-to-severe plaque psoriasis.
The study met both primary endpoints related to the proportion of treated patients achieving PASI 90 (90% skin clearance) at week 16 (non-inferiority) and 52 (superiority) versus Cosentyx.
The new data showed Skyrizi’s superiority as measured by the proportion of patients achieving PASI 100 (clear skin) at week 52. Specifically, 66% of patients in the Skyrizi arm achieved totally clear skin compared to 40% in the Cosentyx arm (p<0.001).
The FDA approved Skyrizi for plaque psoriasis in April 2019.
https://seekingalpha.com/news/3582753-abbvie-reports-additional-data-from-successful-study-of-skyrizi-in-psoriasis

Short regimen hydroxychloroquine plus azithromycin in non-severe Covid-19

José A. Oteo, Pedro Marco, Luis Ponce de León, Alejandra Roncero, Teófilo Lobera, Valentín Lisa

Abstract

The new SARS-CoV-2 infection named COVID-19 has severely hit our Health System. At the time of writing this paper no medical therapy is officially recommended or has shown results in improving the outcomes in COVID-19 patients. With the aim of diminishing the impact in Hospital admissions and reducing the number of medical complications, we implemented a strategy based on a Hospital Home-Care Unit (HHCU) using an easy-to-use treatment based on an oral administration regimen outside the hospital with hydroxychloroquine (HCQ) plus azithromycin (AZM) for a short period of 5 days. Patients and methods: Patients ≥ 18 years old visiting the emergency room at the Hospital Universitario San Pedro de Logrono (La Rioja) between March, 31st and April, 12th diagnosed with COVID-19 with confirmed SARS-CoV-2 infection by a specific PCR, as follows: Patients with pneumonia (CURB ≤ 1) who did not present severe comorbidities and had no processes that contraindicated this therapeutic regime. Olygosimptomatic patients without pneumonia aged ≥ 55 years. Patients ≥ 18 years old without pneumonia with significant comorbidities. We excluded patients with known allergies to some of the antimicrobials used and patients treated with other drugs that increase the QTc or with QTc >450msc. The therapeutic regime was: HCQ 400 mg every twice in a loading dose followed by 200 mg twice for 5 days, plus AZM 500 mg on the first day followed by 250 mg daily for 5 days. A daily telephone follow-up was carried out from the hospital by the same physician. The end-points of our study were: 1.- To measure the need for hospital admission within 15 days after the start of treatment. 2.- To measure the need to be admitted to the intensive care unit (ICU) within 15 days after the start of the treatment. 3.- To describe the severity of the clinical complications developed. 4.- To measure the mortality within 30 days after starting treatment (differentiating if the cause is COVID-19 or something else). 5.-To describe the safety and adverse effects of the therapeutic regime. Results: During the 13 days studied a total of 502 patients were attended in the emergency room due to COVID-19. Forty-two were sent at home; 80 were attended by the HHCU (patients on this study) and 380 were admitted to the Hospital. In our series there were a group of 69 (85.18%) patients diagnosed with pneumonia (37 males and 32 females). Most of them, 57 (82.60%) had a CURB65 score of <1 (average age 49) and 12 (17.40%) a CURB score of 1 (average age 63). Eighteen (22.50%) of the pneumonia patients also had some morbidity as a risk factor. 11 patients (13.75%) without pneumonia were admitted to the HHCU because comorbidities or age ≥ 55 years. Six patients with pneumonia had to be hospitalized during the observation period, 3 of them because side effects and 3 because of worsening. One of these patients, with morbid obesity and asthma, had clinical worsening needing mechanical ventilation at ICU and developed acute distress respiratory syndrome. With the exception of the patient admitted to the ICU, the rest of the patients were discharged at home in the following 8 days (3 to 8 days). Twelve patients (15%), 11 of whom had pneumonia, experienced side effects affecting mainly the digestive. In another patient a QTc interval prolongation (452 msc) was observed. In total 3 of these patients had to be admitted in the Hospital, 2 because of vomiting and 1 because a QTc interval lengthening. None of the patients needed to stop the HCQ or AZM and all the 80 patients finished the therapeutic strategy. From the group without pneumonia only a patient developed diarrhea that did not require hospitalization or stop the medication. Conclusions: Our strategy has been associated with a reduction in the burden of hospital pressure, and it seems to be successful in terms of the number of patients who have developed serious complications and / or death. None of the patients died in the studied period and only 6 have to be admitted in conventional hospitalization area.

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https://www.medrxiv.org/content/10.1101/2020.06.10.20101105v1

Thermo Fisher facing potential speed bump in Qiagen deal

Stephane Mardel, CEO of investment and advisory group United First Partners, tells Bloomberg that Thermo Fisher Scientific (TMO +1.2%) may have to boost its €39-per-share offer for Qiagen (QGEN -0.6%) after proxy advisor Glass Lewis recommended voting against “Top Up” resolutions.
TMO may have to sweeten its bid in order to ensure that enough QGEN shares are tendered. The current threshold is 75%.
The risk of the deal not going through appears minimal however.
https://seekingalpha.com/news/3582697-thermo-fisher-facing-potential-speed-bump-in-qiagen-deal

ADC’s lonca shows encouraging action in blood cancer studies

ADC Therapeutics SA (ADCT +0.8%) announces positive data from two clinical trials evaluating antibody-drug conjugate loncastuximab tesirine (lonca) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The results were virtually presented at EHA.
Interim data from the open-label, single-arm Phase 2 LOTIS 2 study assessing lonca monotherapy showed a 48.3% (n=70/145) overall response rate (ORR), including a 24.1% (n=35/145) complete response rate.
Patients who failed to respond to first-line or last-line prior therapy showed ORRs of 37.9% and 36.9%, respectively.
Median duration of response increased to 10.3 months from 6.7 months in mid-October 2019.
The most common serious/life-threatening treatment-emergent adverse events were neutropenia (25.5%) with low incidence of febrile (fever) neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (enzyme biomarker for liver damage) (16.6%) and anemia (10.3%).
Preliminary data from the open-label, single-arm Phase 1/2 LOTIS 3 trial evaluating the combination of lonca and AbbVie and J&J’s Imbruvica (ibrutinib) showed an ORR of 75.0% and a CR of 58.3% at the recommended Phase 2 dose.
The most common treatment-emergent adverse events were thrombocytopenia (20%) and anemia (12%).
A Phase 3 trial, LOTIS 5, is next up.
https://seekingalpha.com/news/3582683-adcs-lonca-shows-encouraging-action-in-blood-cancer-studies

X4 Pharma’s mavorixafor action positive in rare immune deficiency disorder

X4 Pharmaceuticals (XFOR +3.5%) announces results from an open-label Phase 2 extension study evaluating lead candidate mavorixafor in patients with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a rare inherited immune deficiency disorder caused by mutations in a gene that encodes a protein called CXCR4. The data were virtually presented at EHA.
Sustained dose-dependent increases in white blood cells, neutrophil count and lymphocyte count were achieved which correlated with fewer infections and reduced numbers of warts. Specifically, yearly infection events dropped from 4.63 to 2.27 while the number of warts dropped by an average of 75%.
On the safety front, mavorixafor, a small molecule inhibitor of CXCR4, was well-tolerated over periods of two years or more without serious treatment-related adverse events.
A Phase 3 study is in process. Topline data should be available in 2022.
https://seekingalpha.com/news/3582669-x4-pharmas-mavorixafor-shows-positive-action-in-rare-immune-deficiency-disorder

Cost of cancer care projected to rise 34% by 2030

The cost of cancer-related care is projected to increase 34 percent in the next decade, according to a study published in Cancer Epidemiology, Biomarkers & Prevention.
Researchers looked at 13 years of cancer statistics from the Surveillance, Epidemiology, and End Results Medicare database and used claims from 2007 to 2013 to estimate costs by cancer site, phases of care and stage of diagnosis. Overall cancer care costs, including medical care and oral prescriptions, were $183 billion in 2015, and researchers project that number will increase to $246 billion by 2030, based only on population growth.
The study revealed considerable variation in costs by cancer site and stage. Researchers found that costs at the end-of-life stages were highest at $105,500 per patient per year, followed by the initial phases at $41,800.
https://www.beckershospitalreview.com/oncology/cost-of-cancer-care-projected-to-rise-34-by-2030.html

Sierra Oncology’s momelotinib shows long-term benefit in myelofibrosis

Sierra Oncology (SRRA +7.2%) announces long-term safety and dose intensity data on momelotinib, a JAK1, JAK2 and ACVR1 inhibitor, in more than 550 myelofibrosis patients. The results were presented at EHA.
Over periods as long as 10 years, increases in hemoglobin levels were sustained compared to decreases in those receiving Incyte’s Jakafi (ruxolitinib). Higher mean platelet counts were also observed in patients receiving momelotinib.
No new safety signals or evidence of cumulative toxicity have been observed, including patients receiving full-dose momelotinib.
https://seekingalpha.com/news/3582652-sierra-oncologys-momelotinib-shows-long-term-benefit-in-myelofibrosis