国际新闻精选周六（2017年2月4日）

Fourier love all around as Repatha improves outcomes

Amgen’s worst-case scenario from the outcomes trial of Repatha can be dismissed. The California-based group says the cholesterol-lowering jab reduced risk of heart attacks, strokes and cardiovascular events, raising the odds that insurers will extend coverage to more than just patients with established atherosclerotic disease.【阅读全文】

FDA Accepts Two sBLAs for Merck’s KEYTRUDA (pembrolizumab) for Locally Advanced or Metastatic Urothelial Cancer in Cisplatin-Ineligible First-Line and Second-Line Post-Platinum Failure Treatment Settings

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. Specifically, the application for first-line use was accepted and granted Priority Review for the treatment of these patients who are ineligible for cisplatin-containing therapy. The application for second-line use was also accepted and granted Priority Review for these patients with disease progression on or after platinum-containing chemotherapy. The PDUFA, or target action, date for both applications is June 14, 2017.【阅读全文】

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer
Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo injection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.【阅读全文】

Cancer rates in women rising six times faster than men

Cancer rates will rise six times faster in women than men over the next 20 years, according to new data from Cancer Research UK.

The charity is predicting that UK cancer rates will climb by around half a percent for men and by around three percent for women, which means an extra 4.5 million women and 4.8 million men will be diagnosed with the disease by 2035.【阅读全文】

AstraZeneca pulls PD-L1 phase 3 combo test, RSV candidate

It’s the fourth-quarter clear out, and AstraZeneca has pulled the plug on a combo of its immuno-oncology candidate as well as axing a test of its biologic arm’s RSV drug as it sheds some more light on its birds of prey-themed tests in head and neck cancers.

In the “removed from phase 3” box coming out of its morning presentations on Thursday, Feb. 2, it said it has dropped a late-stage combo treatment of PD-L1 candidate durvalumab and CTLA-4 med tremelimumab (which has seen its own trial setbacks) in first-line metastatic pancreatic ductal carcinoma (the Alps study).【阅读全文】

Leap Therapeutics Presents Biomarker and Efficacy Data at the Cholangiocarcinoma Foundation 2017 Annual Meeting

Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, announced the presentation of biomarker and top-line preliminary efficacy data from its clinical trial of DKN-01 combination therapy in patients with biliary tract cancers at the Cholangiocarcinoma Foundation 2017 Annual Meeting in Salt Lake City, UT.【阅读全文】

Stemline admits it learned of—but did not disclose—patient death in cancer trial before $45M stock offering

Stemline Therapeutics has admitted it learned of a death in its phase 2 cancer trial the day before it went ahead with a $45 million stock offering. The admission follows a report in The Street about the death—the third linked to the same side effect—that wiped more than 40% off Stemline’s stock price.

The events date back to last month. On January 19 Stemline filed a prospectus with SEC to raise money. The offering was priced the following day, generating $45 million for Stemline. What has now become clear, following The Street article and subsequent company statement, is Stemline was told on January 18 of the death of a patient in a phase 2 trial of SL-401. Stemline disclosed its knowledge of the death on February 2. 【阅读全文】

Targovax climbs after posting survival data from I-O trial

Targovax has posted two-year survival data from a phase 1/2 trial of TG01 in resected pancreatic cancer patients. More than 60% of participants were alive two years after starting treatment, sparking a 40% surge in the stock price of Targovax.

The study gave TG01, a peptide-based RAS immunotherapy, in combination with standard of care to pancreatic cancer patients who had undergone resection. Of the 19 evaluable patients, 13 were alive two years after resection. One patient died shortly after passing the milestone, resulting in only 12 patients being alive two years after starting treatment. But whichever start date is used, the two-year survival rate clocks in at upward of 60%.【阅读全文】

Funding sets up proof-of-concept trial for Tarveda's lead Pentarin next year

Boosted by a fresh $30 million tranche of funding, Tarveda Therapeutics will start phase 2 trials of its lead drug for advanced neuroendocrine tumors and small cell lung cancer early next year, according to CEO Drew Fromkin.

Tarveda is focused on developing a new class of drugs called Pentarins that act like antibody-drug conjugates—combining tumor targeting that spares healthy tissues with a toxic payload—but are around 50 times smaller, in principle allowing them to penetrate more deeply into cancers. They are bigger than small molecule drugs, but this is another benefit—it stops them being cleared from the body too quickly, according to the biotech.【阅读全文】

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