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Roche cancer combo extends patients' lives; US FDA changes drug review process

Top news

* Roche Holding AG's cancer drugs Tecentriq and Avastin along with chemotherapy stopped cancer from growing in a phase 3 study among certain lung cancer patients who had not received chemotherapy. Roche's study, named IMpower150, involved 1,202 patients with nonsquamous non-small cell lung cancer having a wild genotype, or WT — a gene in its natural, nonmutated form.

Tecentriq targets programmed death ligand 1, or PD-L1, a protein found on the surface of cancer cells that helps them evade body's cancer-killing immune cells.

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* The U.S. Food and Drug Administration is overhauling both the office that evaluates new medicine applications and its review processes — moves that would improve drug review efficiency by at least 20% overall, according to FDA Commissioner Scott Gottlieb. The changes are intended to keep up with the science of drug development and allow new innovative medicines to get to the U.S. market quicker.

* Several Takeda Pharmaceutical Co. Ltd. shareholders have formed a group lobbying against the company's £46 billion acquisition of Shire, the Financial Times reported, citing anonymous sources. The group, which holds over 1% of the Japanese drugmaker's stock, have hired a former UBS analyst to help with their campaign.

ASCO conference

* Bristol-Myers Squibb Co.'s Opdivo, combined with either a low-dose of Yervoy, or chemotherapy, was more effective than using chemotherapy alone as a first-line treatment for lung cancer in a late-stage study.

According to data from a part of the phase 3 CheckMate-227 trial, combining Opdivo and chemotherapy helped patients with advanced non-small cell lung cancer live longer without the disease worsening. The patient group comprised those whose tumors have very low levels of PD-L1.

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Meanwhile, Bristol-Myers said certain skin cancer patients on its drug Opdivo lived longer while keeping the disease at bay compared to those treated with its drug Yervoy. In a phase 3 study, named CheckMate-238, the company evaluated the treatments in 906 patients with stage IIIB/C or stage IV melanoma who are at a high risk of their disease returning after their tumors are removed by surgery.

* Gilead Sciences Inc. said the response to its chimeric antigen receptor T cell, or CAR-T, therapy Yescarta may help predict longer-term disease control in patients with a type of blood cancer. Yescarta is undergoing a study named Zuma-1 in patients with diffuse large B-cell lymphoma — an aggressive form of non-Hodgkin lymphoma that affects B-lymphocytes, a type of white blood cell.

CAR-T cell therapies work by manipulating a patient's own disease-fighting T cells and then infusing them back into the body to fight blood cancers.

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* Merck & Co. Inc.'s Keytruda reduced tumor size as a stand-alone treatment for patients with small-cell lung cancer in a midstage study named Keynote-158. Under the phase 2 trial, 18.7% patients showed a reduction in tumor size, with 16% of the subjects showing a partial reduction in their disease and 3% of the patients having no detectable cancer — known as a complete response.

Two follow-up studies of Keytruda also showed long-term benefit in patients with advanced skin cancer. Under the Keynote-006 study, 86% of the patients who completed their Keytruda treatment remained alive without the disease worsening after a median follow-up period of 20.3 months while 41.7% of the patients in the Keytruda treatment arm remained alive for four years, compared to 34.1% for the Yervoy treatment group.

The Keynote-001 study, which evaluated Keytruda in patients with various advanced cancers including advanced melanoma, 41% of patients on Keytruda saw a reduction in the size of their tumors while 52% of the patients who had not received prior treatment saw their tumors shrink.

Meanwhile, a separate ongoing study of Keytruda called Keynote-427 showed the therapy's anticancer effect in almost 40% of patients with a form of advanced kidney cancer. Interim data from the mid-stage study showed that 38.2% of patients with advanced clear cell renal cell carcinoma who received Keytruda experienced tumor size reduction over a median follow-up period of 12.1 months.

* Pfizer Inc. said its investigational compound dacomitinib showed a seven-month improvement in overall survival of lung cancer patients compared to AstraZeneca PLC's Iressa. The results are from a phase 3 study, called Archer 1050, which enrolled patients with locally advanced or metastatic non-small cell lung cancer with mutations related to epidermal growth factor receptor.

* CytomX Therapeutics Inc.'s CX-072, which targets PD-L1, was well tolerated as a standalone treatment and showed anti-tumor activity in a phase 1/2 study of patients with advanced solid tumors that cannot be removed through surgery. The Proclaim-072 study is evaluating the drug as a monotherapy and in combination with Bristol-Myers' Yervoy or Roche's Zelboraf.

Drug and product pipeline

* The U.S. FDA accepted Roche's application for Hemlibra as a therapy for hemophilia A patients without factor VIII inhibitors and granted the drug priority review. The regulator is expected to make a decision on Hemlibra's approval by Oct. 4.

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* Mylan NV and Biocon Ltd. received U.S. FDA approval for Fulphila, the first biosimilar to Amgen Inc.'s blockbuster blood cancer therapy Neulasta. The biosimilar is now approved to decrease the chance of infection from febrile neutropenia as a result of chemotherapy in patients with non-myeloid, or non-bone cancer.

* Eisai Co. Ltd. said its investigational Alzheimer's drug, elenbecestat, demonstrated safety and tolerability in patients at a higher dose. The 70 patients participating in a mid-stage clinical study called Study 202 had been diagnosed with either mild cognitive impairment due to Alzheimer's disease, or mild to moderate dementia due to Alzheimer's disease.

Operational activity

* AstraZeneca is planning to disclose its payments to doctors in all countries it operates in, The Times (London) reported. Usually, drug companies only reveal their payments to doctors in countries where the law requires them to.

* Judges on the U.S. Court of Appeals for the Federal Circuit in Washington questioned Allergan PLC's use of an American Indian tribe's immunity to prevent challenges to its patents and asked if it was a ploy to avoid review by the Patent and Trademark Office, Bloomberg News reported.

Our features

China's 1st rare disease list seen as major step toward further policy reforms: The country — home to more than 16 million rare disease patients — is expected to introduce more regulations for orphan drug research and development, and medical insurance for diagnosis and treatment.

Other features

* A majority of people who get treated at U.S. emergency rooms for mild brain injuries fail to receive follow-up care within the next three months, Reuters writes.

* CNBC has a feature on telehealth, which is emerging as an attractive option for men seeking help for mental health problems.

* The prices for common estrogen medications have doubled since 2014, GoodRx writes in a feature. The therapies are used for treating symptoms of menopause.

* A team from Stanford has developed a new risk calculator that could more accurately determine the risk of heart disease and stroke for patients among multiple populations, STAT has a feature.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, Hang Seng gained 0.31% to 31,093.45, while the Nikkei 225 rose 0.28% to 22,539.54.

In Europe, around midday, the FTSE 100 dropped 0.33% to 7,715.60, and the Euronext 100 lifted 0.55% to 1,070.93.

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