September 1, 2017
By Mark Terry, BioSpace.com Breaking News Staff
In recent years, AstraZeneca has put a lot of its resources into oncology. The company’s Imfinzi (durvalumab) has done quite well in several clinical trials, but had a big setback in July when it failed a Phase III clinical trial as a monotherapy or in combination with tremelimumab for non-small cell lung cancer (NSCLC). But investors are eagerly looking forward to data the company expects to present at the European Society for Medical Oncology (ESMO) congress in Madrid on September 9.
The two studies, PACIFIC and FLAURA, have already met their pre-defined goals, but details are pending.
On May 12, the PACIFIC trial had positive results in evaluating Imfinzi as sequential treatment in locally-advanced, unresectable (Stage III) NSCLC in patients who had not progressed after receiving platinum-based chemotherapy concurrent with radiation therapy. A planned interim analysis by an Independent Data Monitoring Committee (IDMC) decided that the trial had already met its primary endpoint—statistically significant and clinically-meaningful PFS. It also showed a favorable benefit/risk profile.
On July 27, AstraZeneca announced that the Phase III FLAURA trial showed a statistically significant and clinically meaningful progression-free survival benefit with Tagrisso (osimertinib) compared to the current first-line standard-of-care treatment (erlotinib or gefitinib) in NSCLC.
Reuters notes that, regarding the PACIFIC study, “There are currently no approved treatments for this stage of disease and strong data could open up a $1 billion-plus opportunity—though it will still be smaller than for late-stage disease, where a combination of Imfinzi and tremelimumab failed to work as hoped.”
AstraZeneca won’t be the only company presenting data that will have investors eagerly hoping their stocks will climb. Eli Lilly (LLY) is providing data on how its CDK4/6 drug abemaciclib compares to similar drugs marketed by Pfizer and Novartis . And Bristol-Myers Squibb , Merck & Co and Roche will also be providing updates on their immuno-oncology products.
And as interesting as those will be, with possible catalytic events likely to occur, part of the fun is when something unexpected happens, such as at the June American Society of Clinical Oncology (ASCO) meeting in Chicago. One of the big stories at that time was a surprise presentation by China’s Nanjing Legend Biotech that had stunning results in early multiple myeloma (MM) for its CAR-T product.
In that case, Nanjing Legend presented data in 35 relapsed, drug-resistant patients with MM. Thirty-three, or 94 percent, showed clinical remission that ranged from complete to partial response. According to the presentation, there was a 100 percent objective response rate.
It’s been only a month since AstraZeneca announced it was halting six pipeline programs. The company is being hit hard by patent expirations, particularly Crestor, whose sales dropped by 29 percent in the second quarter of this year and 15 percent in the last six months. But its legacy drugs, in general, are faltering, although oncology drug Faslodex is growing by about 20 percent or more in the last half, and its cardiovascular drugs Brilinta and Farxiga are growing as well, by 49 percent and 64 percent in the second quarter, respectively. But overall total revenues were down by 3 percent, and reported earnings per share (EPS) dropped 45 percent.
The six pipeline programs, mostly from the MedImmune biologics division, included a Phase III combination trial of Epanova (omega-3 carboxylic acids), for triglycerides levels, and Farxiga (dapagliflozin) for liver disease NASH. It also killed a late-stage GOLD study of Lynparza (olaparib) in second-line gastric cancer.
