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The 2019 Annual Meeting of the American Society of Clinical Oncology takes place from May 31 to June 4.* Seattle Genetics Inc.'s urothelial cancer drug alone reduced tumors in a mid-stage study in almost half of patients, all of whom had seen their disease return after receiving chemotherapy and immunotherapy.
The phase 2 single-arm study, also funded by Tokyo-based Astellas Pharma Inc., showed that 44% of the total 125 participants experienced shrinkage of their tumors, or no growth, while 12% of those treated had no signs of cancer after treatment. The median time participants survived was 11.7 months, the companies said June 3.
AstraZeneca PLC and Merck & Co. Inc. said their drug Lynparza extended the lives of pancreatic cancer patients without the disease worsening by almost double in a late-stage study dubbed Polo. In patients with pancreatic cancer that had spread, those taking Lynparza lived for 7.4 months without the disease getting worse, while those not taking Lynparza lived 3.8 months without progressing disease, AstraZeneca and Merck announced at the 2019 Annual Meeting of the American Society of Clinical Oncology, or ASCO.
Also announced at the ASCO meeting were results from Myriad Genetics Inc. that showed its BRACAnalysis CDx companion diagnostic was effective at identifying patients with pancreatic cancer who would benefit from Lynparza.
* A New York court jury ordered Johnson & Johnson to pay $300 million in punitive damages to Donna Olson, who claimed that the company's baby power contained asbestos and caused her cancer, The Wall Street Journal reported. The same jury had already awarded Olson $25 million in compensatory damages. A J&J spokesman told the Journal that it will appeal for a reversal as the trial had legal errors.
* Women under the age of 65 were more likely to receive early-stage diagnosis and treatment for ovarian cancer after the Affordable Care Act became effective, according to a study released at the ASCO meeting.
* Lonza Group Ltd. said it will carve out its specialty ingredients division, resulting in 130 redundancies. The segment will operate under independent management but will remain a fully owned division of the Swiss healthcare company.
In April, Lonza said its specialty ingredients segment, which focuses on consumer health services, performed below expectations with sales on the same level as the first quarter of 2018 due to softening demand and clients' changing order patterns.
On the policy front
* A plan proposed by House Speaker Nancy Pelosi, D-Calif., for a scaled-back version of Medicare drug price negotiations got some new support from a group of patient advocates last week. A new analysis from the nonprofit Patients for Affordable Drugs found that 1% of the drugs covered by Medicare Part D, which covers medicines for seniors and disabled Americans, picked up at the pharmacy counter accounted for 17% of the program's spending. About 3.5% of the drugs accounted for 60% of Medicare Part D spending.
Meanwhile, a new analysis by Avalere Health found that if Congress required Medicare under its Part B program to support out-of-pocket costs for lower-cost versions of biologics, or biosimilars, beneficiaries' costs could drop by up to $3.3 billion over 10 years, and federal spending would decrease by as much as $5.2 billion.
* Top U.S. Food and Drug Administration officials acknowledged the complexities they face in regulating products containing cannabidiol, admitting that regulators are far from answering a multitude of questions as they grapple with their new terrain. Acting FDA Commissioner Ned Sharpless said the agency has formed an internal working group to address the gaps in the agency's knowledge about CBD and to figure out a pathway for regulating the products, which are increasingly being illegally marketed in the U.S. in a number of forms.
A public comment period will remain open until June 30, after which the Utah DOH will submit the waiver to the Centers for Medicare and Medicaid Services.
M&A and capital markets
* BC Partners and CVC Capital Partners Ltd. are among private equity firms considering acquiring Bayer AG's animal health unit, which could sell for as much as €8 billion, the Financial Times reported. Cinven Ltd. and Permira Holdings Ltd. are examining a joint proposal, while Advent International Corp. and other U.S. buyout firms are also interested in the business, the report noted.
ASCO conference
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* Merck & Co. said its blockbuster immunotherapy Keytruda helped patients live for five years with advanced non-small cell lung cancer in an early-stage study that is the longest trial conducted with the drug in that type of cancer. Merck & Co. presented the results during the 2019 ASCO meeting.
* According to the final analysis from a study called Keynote-048, Keytruda alone and in combination with chemotherapy helped patients with head and neck cancer live longer than those taking only chemotherapy.
* Still presenting at the ASCO meeting, Merck & Co. said Keytruda helped patients with stomach cancer live for two years at a rate comparable to chemotherapy treatments and with fewer side effects in a late-stage study. Keytruda is approved for 19 types of cancer in the U.S., including previously treated gastric cancer with PD-L1 expression.
* Meanwhile, Johnson & Johnson said a combination of its cancer drug Erleada and standard hormone therapy helped extend the lives of patients with metastatic castration-sensitive prostate cancer in a late-stage clinical trial. Results from a phase 3 study, named Titan, showed that Erleada plus androgen deprivation therapy, or ADT, extended survival versus placebo plus ADT, with a 33% reduction in the risk of death.
* An independent late-stage study of Astellas Pharma Inc.'s and Pfizer Inc.'s treatment Xtandi found that men with metastatic hormone-sensitive prostate cancer lived longer with the drug than with anti-androgen drugs — including bicalutamide, nilutamide or flutamide. However, Xtandi presented more side effects than the other drugs: 42% taking Xtandi had serious adverse events while only 34% of patients on one of the other drugs experienced such problems.
* Novartis AG said its drug Kisqali combined with endocrine therapy helped more breast cancer patients live for 3.5 years than endocrine therapy alone in a late-stage trial. In the Monaleesa-7 trial, 70% of premenopausal women with advanced HR-positive, HER2-negative breast cancer lived for 42 months on the combination treatment, while of those who only had endocrine therapy, 46% lived that long.
* Novartis said INC280, or capmatinib, showed promise in a phase 2 clinical trial as a potential treatment for patients with non-small cell lung cancer with a rare mutation. Results from the Geometry mono-1 study showed that the drug shrank tumors in 68% of patients who had never received treatment and in 41% of previously treated patients, as measured by a metric called overall response rate — the study's main goal.
* AstraZeneca said its drug Imfinzi showed long-term promise in a phase 3 clinical trial in patients with stage 3 non-small cell lung cancer whose tumors cannot be removed through surgery. Three-year results from the Pacific study showed the drug extended patients' lives longer than placebo in lung cancer patients whose diseases had not progressed following concurrent chemoradiation therapy.
The 2019 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from around the world, with more than 2,400 study abstracts to be presented on-site and an additional 3,200 abstracts to be published online.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng was down 0.08% to 26,880.45, and the Nikkei 225 fell 0.92% to 20,410.88.
In Europe, around midday, the FTSE 100 was down 0.39% to 7,133.74, and the Euronext 100 was down 0.39% to 1,018.09.
Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.
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