Top news
* Merck & Co. Inc.'s Keytruda, as a standalone treatment, improved the life expectancy of certain nonsquamous or squamous non-small cell lung cancer patients in a late-stage trial dubbed Keynote-042. Keytruda boosts the immune system's ability to kill cancer cells by blocking healthy cells' PD-1 protein from linking up with a partner arm on the surface of cancer cells known as the PD-L1 protein.
Results from the trial showed that patients whose tumors showed a PD-L1 level of 50% or more lived for a median of 20 months on the Merck drug, compared with 12.2 months on platinum-based chemotherapy.
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* The U.S. Food and Drug Administration this week is expected to unveil its much-anticipated plans to overhaul the reviewing process for bringing new medicines to the U.S. market quicker, Commissioner Scott Gottlieb said at the annual meeting of the American Society of Clinical Oncology, or ASCO. Gottlieb and other top FDA officials have been hinting for months that the restructuring of the agency's Office of New Drugs was coming.
Gottlieb also revealed two pilot programs — real-time oncology reviews and a new assessment tool — intended to speed cancer drugs to the market.
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ASCO conference
* Roche Holding AG said a combination of Tecentriq and chemotherapy reduced the risk of the disease worsening or death in a phase 3 study, named IMpower131, among patients with previously untreated advanced squamous non-small cell lung cancer. The study results showed that patients on the combination lived for a median of 6.3 months without the disease worsening, compared to 5.6 months for patients receiving chemotherapy drugs carboplatin and Celgene Corp.'s Abraxane.
Meanwhile, Roche said it is dropping plans to develop cancer drug taselisib after its combination with AstraZeneca PLC's Faslodex did not produce significant benefit and had serious side effects in a late-stage study. The Swiss drugmaker evaluated the combination in a phase 3 trial of breast cancer patients whose disease growth was due to the hormone estrogen, had grown to nearby tissue or other parts of the body and had a mutation in the PIK3CA gene.
* Celgene and Bluebird Bio Inc.'s chimeric antigen receptor T cell, or CAR-T therapy, showed disease reduction in certain late-stage blood cancer patients and extended their life while keeping the disease at bay under a phase 1 trial. The study evaluated bb2121 in patients with late-stage multiple myeloma whose disease had returned or did not respond to treatment.
In a separate phase 1 trial, another CAR-T therapy from Celgene called liso-cel was shown to remain effective in patients with an aggressive form of non-Hodgkin lymphoma six months after treatment. Results from the study showed that 49% of 37 patients — who were treated with a dose of 100 million CAR-T cells — remained in remission six months after treatment with liso-cel.
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A separate phase 3 study saw Celgene's Pomalyst, in combination with bortezomib and dexamethasone, extend the life of certain multiple myeloma patients while keeping the disease at bay.
* Loxo Oncology Inc. said early stage data on its experimental cancer drug Loxo-292 showed that the therapy caused tumors to shrink in nearly 80% of patients with a rare genetic mutation. Interim data from the study dubbed Libretto-001 showed the medicine helped shrink tumor size in 77% of the 39 evaluable patients who had rearranged-during-transfection fusions and mutations.
* Nektar Therapeutics' NKTR-214 in combination with Bristol-Myers Squibb Co.'s Opdivo shrank the tumors of patients with certain advanced cancers in a phase 1/2 trial. The study, called Pivot, evaluated the combination in patients with stage IV metastatic melanoma, or skin cancer, renal cell carcinoma or kidney cancer, and urothelial cancers — a type of bladder cancer.
Opdivo is a programmed cell death protein 1, or PD-1 inhibitor, that boosts immune cells' ability to kill cancer cells, and NKTR-214 is designed to activate specific cancer-fighting immune cells directly in the tumor and increase expression of PD-1 on these immune cells.
* Merck KGaA said its cancer therapy M7824 showed a manageable safety profile in the dose escalation portion of an early stage study on patients with solid tumors who have had previous treatment.
M&A and capital markets
* Bayer AG announced a €6 billion cash call to help fund its pending $62.5 billion acquisition of Monsanto Co. The German drug and chemicals maker is expecting to complete the acquisition on June 7 and said it will retire the Monsanto name upon completion.
* Novartis AG completed the $13 billion sale of its 36.5% stake in a consumer healthcare joint venture it had created with GlaxoSmithKline PLC in 2015.
Drug and product pipeline
* The U.S. FDA lifted a partial clinical hold on Bristol-Myers' phase 3 study to evaluate Opdivo in combination with other drugs in patients with multiple myeloma who are not responsive to treatment or whose disease has returned following treatment.
* The U.S. FDA approved the 2-milligram dose of Eli Lilly and Co. and Incyte Corp.'s rheumatoid arthritis drug Olumiant. The regulator approved Olumiant with a boxed warning, the agency's most prominent warning, for the risk of serious infections leading to hospitalization or death.
* The U.S. FDA rejected Amgen Inc.'s ABP 980, a biosimilar to Roche's breast cancer drug Herceptin. The company said it received a complete response letter from the FDA and that it plans to work closely with the regulator regarding the biosimilar.
Operational activity
* Imerys unit Imerys Talc America agreed to pay at least $5 million to settle a lawsuit filed by 22 women who accused the mining company of supplying Johnson & Johnson with asbestos-laced talc that caused their cancers, Bloomberg News reported.
Our features
Japan drugmakers post growth overseas, as price revisions scuttle local sales: Nine of the country's top 10 drugmakers reported an increase in overseas sales, and a drop in local revenues, as changes implemented by Japan's National Health Insurance in April 2016 continued to impact earnings.

Other features
* The Wall Street Journal has a feature about how doctors, backed by new studies, could prescribe less chemotherapy and surgery for certain cancer patients to avoid side effects and steep costs.
* The New York Times writes about so-called fecal transplants which could be as effective as antibiotics when treating a certain gut infection.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng was up 1.66% to 30,997.98. The Nikkei 225 rose 1.37% to 22,475.90.
In Europe, as of midday, the FTSE 100 was up 0.31% to 7,701.77, and the Euronext 100 climbed 1.02% to 1,059.77.
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