AbbVie Moves Ahead on Plaque Psoriasis Application and Arthritis Clinical Trial


By Mark Terry

AbbVie has submitted a Biologics License Application (BLA) to the U.S. FDAfor risankizumab, an interleukin-23 (IL-23) inhibitor for plaque psoriasis.

The application is based on data from four Phase III clinical trials: ultIMMA-1, 2, IMMhance and IMMvent. The drug met all co-primary and ranked secondary endpoints with no new safety problems.

The drug was developed in a collaboration with Boehringer Ingelheim.

In the trials, more than 2,000 patients were treated.

“The risankizumab submission represents an important milestone in our goal of advancing treatment for people living with immune-mediated diseases,” said Michael Severino, AbbVie’s executive vice president, research and development and chief scientific officer. “Risankizumab has the potential to be an important treatment option for people living with plaque psoriasis and we look forward to working with the FDA throughout the review process.”

AbbVie also announced positive data from its ongoing Phase IIB/III SELECT-SUNRISE clinical trial. This trial evaluated upadacitinib in Japanese patients for moderate to severe rheumatoid arthritis. The data showed that at 12 weeks, all doses, 7.5mg, 15mg, 30mg, once-daily, met the primary endpoint of ACR20alpha compared to placebo.

“We are encouraged by these data, which show that upadacitinib provides improvements in important measures such as achieving ACR response and clinical remission, in people living with rheumatoid arthritis in Japan,” Severino said in a statement. “SELECT-SUNRISE reflects our continued commitment to offering innovative solutions with the potential to improve the lives of Japanese patients living with this serious, debilitating condition.”

Upadacitinib was discovered and developed by AbbVie. It is an oral drug that inhibits JAK1, which is linked to various immune-mediated diseases, including rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease. In addition to those diseases, the drug is being evaluated for ulcerative colitis, ankylosing spondylitis, atopic dermatitis and giant cell arteritis.

AbbVie will be releasing its first-quarter financials tomorrow. In the last quarter, it reported a 2.78% increase in earnings, which was more than most analysts expected. Generally, the stock has outperformed the industry this year, which may not be saying much. The industry has shown an overall drop of 4.3% and AbbVie’s have decreased 4.1%.

Shares are currently trading for $91.3. The 52-week high was $125.86 and the low was $64.61. Shares opened today at $90.96.

Also today:

PixarBio CEO and 2 Associates Arrested and Charged with Fraud

Stock Dives as Celldex Cuts 20% of Staff After Phase II Breast Cancer Failure

Corvidia Raises $60 Million Series B to Push into the Clinic

Novartis Joins Innovative Solution Trend for Clinical Trials: Launches FocalView App

Amgen’s New Products Deliver Double-Digit Growth While Facing Down Pricing Pressure for New Migraine Drug

AstraZeneca’s Imfinzi Double-Combo Fails to Impress

By Mark Terry

AstraZeneca and MedImmune announced that their Phase III ARCTIC clinical trial in locally-advanced or metastatic non-small cell lung cancer (NSCLC) in patients who received a least two prior treatments failed to hit its primary endpoint.

The trial was looking at a combination of Imfinzi (durvalumab) and tremelimumab, as well as Imfinzi and tremelimumb by themselves, compared to standard-of-care chemotherapy in patients with PDL1-low/negative. It also looked at Imfinzi alone versus standard chemo in patients with high PDL-1.

Sub-study B, which was in PDL-1-low/negative lung cancer, the combination of Imfinzi and tremelimumab did not meet the primary endpoints, which were progression-free survival (PFS) and overall survival (OS) compared to standard of care.

The company stated that “sub-study A was not powered for statistical significance,” but goes on to say Imfinzi by itself had a clinically-meaningful decrease in the risk of death compared to standard chemotherapy.

“While we are disappointed that the combination of Imfinzi plus tremelimumab did not result in a statistically-significant benefit in this heavily pre-treated patient population, we are encouraged by the activity of Imfinzi monotherapy observed in this trial and look forward to presenting the full data form the ARCTIC trial at an upcoming medical meeting,” stated Sean Bohen, AstraZeneca’s executive vice president, Global Medicines Development and chief medical officer.

The ARCTIC trial was a randomized, open-label, multi-center, global Phase III trial. Tumor PD-L1 expression was evaluated using the Ventana PD-L1 (SP263) assay with PD-L1 high defined as 25% or more tumor cells with membrane staining.

Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80. It basically keeps tumors from hiding from the body’s immune system. Tremelimumab is also a fully human monoclonal antibody, in this case, against CTLA4. It is an immune checkpoint blocker.

The U.S. FDAapproved Imfinzi for patients with unresectable, Stage III NSCLC whose disease hadn’t progressed after platinum-based chemo and radiation therapy. It’s also been granted accelerated approval in the U.S. for locally-advanced or metastatic urothelial carcinoma after disease progression after platinum-based chemo, or in patients whose disease progressed within a year of receiving platinum-containing chemo before or after surgery.

Following in the footsteps of HIV treatment, immuno-oncology has been working on the value of combination therapies, but the results of this study undercut the possibilities—although not by too much. Reutersnoted, “The results of the study, known as ARCTIC, is disappointing but not a huge surprise, since evidence has been building that there may be little value in using a so-called CTLA-4 drug like tremelimumab on top of a PD-L1 such as Imfinzi.”

Like most therapies, monotherapy or combinations, it depends on the diseases and the drugs. Because Imfinzi showed some efficacy, but adding tremelimumab didn’t, there’s a possibility that adding tremelimumb offset Imfinzi’s efficacy. Immuno-oncology therapies with traditional chemo appear to be effective, but adding multiple immuno-therapies together, at least as demonstrated by this study, do not seem terribly effective.

Reuters went on to write, “A year ago, the notion of combining the two medicines was the big hope driving AstraZeneca’s stock price—but that hope was dealt a major blow in July when its main first-line lung cancer trial, called MYSTIC, failed to slow disease progression.”

AstraZeneca is planning to report overall survival data from the MYSTIC trialin the second half of this year. MYSTIC is evaluating Imfinzi alone or in combination with tremelimumb compared to standard chemo in patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally-advanced or metastatic (Stage IV) first-line NSCLC.

As of this writing, AstraZeneca stock is up about 1.3% in trading, hitting $35.08. It dropped slightly at opening, but is recovering.

Also today:

Takeda Pharma and Shire Come Back to the Negotiating Table

New Sanofi R&D Boss Marks Yet Another High-Profile Industry Executive Change

Revolution Medicines Raises Another $56 Million and Completes Pivot from Antifungal to Cancer Company

Eli Lilly’s Arthritis Drug Gets Mixed Recommendation, But Reports Strong Quarter

Cedilla Therapeutics Launches with $56.2 Million


Welcome to BioPharmBiz. This site will present news and insight related to the biopharmaceutical industry—biotech, pharmaceuticals and medical devices. The site is under construction at the moment, so please be patient.



Mark Terry