Target $6
Friday, March 19, 2021
Kiniksa: FDA Approves ARCALYST for Recurrent Pericarditis
Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, today announced the U.S. Food and Drug Administration (FDA) approved ARCALYST ® (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling, for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and children 12 years and older. The commercial launch is expected in April 2021.
Clovis Oncology’s Rubraca Improves Progression-Free Survival v. Chemo in Ovarian Cancer
Data from the randomized, Phase 3 ARIEL4 study to be presented today at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer
The ARIEL4 study met its primary endpoint, showing a statistically significant improvement in investigator-assessed progression-free survival (PFS) for Rubraca versus chemotherapy
The safety of Rubraca observed in the ARIEL4 study was highly consistent with both the U.S. and EU product labels
Clovis Oncology, Inc. (NASDAQ: CLVS) announced that the first presentation of data from the randomized, Phase 3 ARIEL4 study of Rubraca® (rucaparib) will take place today in an oral presentation at the Society of Gynecologic Oncology Virtual Annual Meeting on Women’s Cancer (SGO). The data demonstrate that Rubraca significantly improves PFS compared to standard-of-care chemotherapy, including platinum-based chemotherapy, among patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation who have received two or more prior lines of chemotherapy.
"Data from the ARIEL4 study meaningfully enhance our understanding about the role of Rubraca among women with BRCA mutation-positive relapsed ovarian cancer, as well as the clinical relevance of BRCA reversion mutations," said Dr. Rebecca Kristeleit, Co-Coordinating Investigator of ARIEL4 and Consultant Medical Oncologist, Guy’s and St Thomas’ NHS Foundation Trust, London, UK. "This is important because women with more advanced disease have fewer treatment options, and it is increasingly important to understand how specific mutations affect treatment outcomes."
Dr. Kristeleit will present "Rucaparib versus chemotherapy in patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation: efficacy and safety from ARIEL4, a randomized phase 3 study" today during the SGO Scientific Plenary I: Innovation and Progress in Gynecologic Oncology session from 2:35 pm - 3:45 pm CT. The presentation can also be viewed at https://www.clovisoncology.com/pipeline/scientific-presentations/ starting today at 2:35 pm CT.
FDA approves J&J's multiple sclerosis treatment
The U.S. Food and Drug Administration has approved Johnson & Johnson’s multiple sclerosis (MS) treatment, Ponvory, the company’s unit Janssen Pharmaceutical Co said on Friday.
The FDA approved Ponvory as a daily oral drug to treat relapsing forms of multiple sclerosis, a debilitating neurological condition in which the immune system eats away at the protective covering of nerves.
The approval was based on data from a two-year late-stage study where Ponvory demonstrated superior efficacy in significantly reducing annual relapses by about 30% compared to Sanofi's approved MS drug Aubagio, the company said. (refini.tv/3c1kjcz)
Ponvory is also under review by the European Medicines Agency (EMA).
Oramed Forms JV, Oravax Medical, to Develop Novel Oral COVID-19 Vaccine
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has entered into definitive agreements to form a joint venture focused on the development of novel oral COVID-19 vaccines. The new company, Oravax Medical Inc., is based on Oramed's proprietary POD™ oral delivery technology and Premas Biotech Pvt. Ltd.'s novel vaccine technology.
Oravax's COVID-19 vaccine candidate benefits from being a virus like particle (VLP) triple antigen vaccine that targets three structural proteins, which should make it a better candidate for protection across emerging mutations of the coronavirus. The oral delivery of the vaccine should allow for widescale inoculation and easier distribution of the vaccine without requiring an injection.
In a pilot animal study, the oral COVID-19 vaccine promoted both systemic immunity through Immunoglobulin G (IgG), the most common antibody in blood and bodily fluids that protects against viral infections, and Immunoglobulin A (IgA).
Oravax anticipates commencing a clinical study during the second quarter of 2021.
Thursday, March 18, 2021
Acupuncture Tops Usual Care for Pain in Cancer Survivors
Two types of acupuncture significantly reduced chronic musculoskeletal pain in cancer survivors as compared with usual care, a randomized trial showed.
Electroacupuncture reduced patient-reported pain by 1.9 points versus usual care, and auricular acupuncture reduced patients' mean pain score by 1.6 points as compared with usual care, which consisted of analgesics, physical therapy, and steroid injections.
Auricular acupuncture, developed by the U.S. military and widely used in VA health facilities, failed to achieve noninferiority to electroacupuncture and was associated with more adverse events (AEs), reported Jun J. Mao, MD, of Memorial Sloan Kettering Cancer Center in New York City, and co-authors in JAMA Oncology.
"The magnitude of effect of electroacupuncture was clinically important and durable," the authors wrote. "This finding is consistent with evidence from other large acupuncture trials for chronic pain in the general population. Electroacupuncture has been shown to influence endogenous opioid release, which provides a mechanistic basis for chronic pain management."
"The present trial includes a large and diverse group of cancer survivors and provides evidence that electroacupuncture provides additional benefits beyond usual care, including not only reduction in pain severity, but also improvements in physical function and quality of life and reductions in analgesic use."
The U.S. has a growing population of cancer survivors, who have a greater pain burden than the general population. Almost half of cancer survivors receive inadequate pain relief, adversely affecting quality of life, physical function, and cancer-related outcomes.
A large body of evidence supports the superiority of acupuncture over usual care for relief of chronic noncancer pain, and last year CMS approved coverage of acupuncture for chronic lower back pain. A recent meta-analysis showed that acupuncture reduced cancer-associated pain, but the strength of evidence was considered moderate because of trials' small sample sizes and heterogeneity of acupuncture techniques.
Mao and colleagues reported findings from the largest randomized trial to date of acupuncture for cancer-related pain. The multicenter PEACE study enrolled adults with a history of cancer but no current evidence of disease. Eligible patients had musculoskeletal pain for at least 3 months and at least 15 of the preceding 30 days and a worst pain intensity within the past week of ≥4 (moderate or greater) on the 0-10 scale of the Brief Pain Inventory (BPI).
Patients were randomized 2:2:1 to electroacupuncture, auricular acupuncture, or usual care. Licensed experienced acupuncturists provided both types of acupuncture. During electroacupuncture, needles were placed at four sites near the pain location and four additional sites elsewhere on the body to address comorbid symptoms. The angle and depth of insertion were individualized to each patient's body type and point location. Treatment consisted of 10 once-weekly 30-minute sessions.
The protocol for auricular acupuncture, often called "battlefield acupuncture," was standardized and began with insertion of one needle into the cingulate gyrus of one ear. The patient then walked for 1 minute. If pain remained ≥1 on the BPI, another needle was inserted into the other ear. The process was repeated for the remaining ear points: thalamus, omega 2, point zero, and shen men.
The primary endpoint was change in average BPI score from baseline to week 12, and data analysis included 360 patients. Of 145 patients randomized to electroacupuncture, 136 (93.8%) completed at least eight sessions, as did 117 of 143 (81.8%) patients assigned to auricular acupuncture.
Mean baseline BPI scores ranged from 5.0 to 5.6. The most common sites of pain across all three groups were lower back (27.8% to 36.6%), knee/leg (14.5% to 23.6%), and hip/thigh (11.0% to 12.5%). At week 12, mean BPI score had declined by 0.48 in the usual care group, 2.39 in the electroacupuncture group (P<0.001), and 2.03 in the auricular acupuncture group (P<0.001). The 0.36 difference between the two acupuncture groups exceeded the prespecified noninferiority margin of 0.657 for auricular versus electroacupuncture.
AEs in both acupuncture groups were mild or moderate. Bruising was the most common AE in the electroacupuncture group (10.3%), and ear pain was most common with auricular acupuncture (18.9%). Only one patient (0.7%) discontinued electroacupuncture because of an AE, as compared with 15 (10.5%) in the auricular acupuncture group (P<0.001).
Disclosures
The study was supported by the Department of Defense and the National Cancer Institute.
Mao disclosed relationships with the Tibet Cheezheng Tibetan Medicine Co. and Zhongke Health International.
Pending Jak verdicts take on greater significance
More evidence emerged yesterday to suggest that an era of regulatory permissiveness is ending in the US: the FDA seems to be taking a closer look at the safety of the Jak inhibitor class. A delay to new approval decisions for Abbvie's Rinvoq sliced $10bn, or 5%, from the company's market cap; sellside revenue forecasts show that Abbvie potentially has the most to lose here, should toxicity concerns prompt the regulator to try to restrict these drugs' use. With several other regulatory decisions on the Jak class looming, the extent of the FDA's worries should soon become clear. Both of Pfizer's Jaks are awaiting verdicts: a line extension into ankylosing spondylitis for the older Xeljanz and a much more important first approval for the follow-on project abrocitinib in atopic dermatitis. The latter is a disease in which serious safety concerns will not be tolerated, as it is considered less severe than Jak settings like RA. Lilly too has an atopic dermatitis decision pending for Olumiant. Investors should also be considering the broader message: Leerink analysts believe that any phase III project with known controversies should be considered at heightened risk of delay, a complete response letter or restricted labelling.
| Crunch time: regulatory decisions on the horizon for the Jak inhibitor class | ||
|---|---|---|
| Product | Company | US and EU decisions due |
| Jyseleca (Jak1) | Galapagos/Gilead | EMA decision in ulcerative colitis due H2 2021 |
| Abrocitinib/PF-04965842 (Jak 1) | Pfizer | FDA decision in atopic dermatitis due Apr 27; EMA decision due H2 2021 |
| Rinvoq (Jak 1) | Abbvie | Psoriatic arthritis delayed 3mth to late Q2 2021; FDA decisions expected in ankylosing spondylitis in Q2 and atopic dermatitis in Q3, but could also be delayed; EMA atopic dermatitis decision expected Q3 2021 |
| Xeljanz (Jak 1, 2 & 3) | Pfizer | FDA decision in ankylosing spondylitis expected Q2 2021 |
| Olumiant (Jak 1 & 2) | Lilly | FDA decision in atopic dermatitis due Q2 2021 (based on Q2 2020 submission) |
| Source: Evaluate Omnium. | ||
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