Roche's Investigational Cancer Immunotherapy Atezolizumab (Anti-PDL1, MPDL3280A) Shrank Tumours in Two Thirds of People with the Most Common Type of Lung Cancer When Combined with Chemotherapy in a Phase 1b Study

“Roche (SIX: RO, ROG; OTCQX: RHHBY) will present encouraging results from a Phase Ib study of the investigational cancer immunotherapy atezolizumab (MPDL3280A), in combination with a range of platinum-based chemotherapy combinations commonly used in the treatment of non-small cell lung cancer (NSCLC). The study showed that atezolizumab, a PD-L1 (programmed death ligand-1) inhibitor, shrank tumours (objective response rate; ORR) in 67 percent (20/30) of people with advanced NSCLC when combined with chemotherapy. The addition of atezolizumab to chemotherapy was well tolerated and no unexpected toxicities were reported. The most frequent adverse events (AEs) included those commonly associated with chemotherapy, such as nausea, fatigue and constipation. The data will be presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO).1

” ‘We are encouraged that a high proportion of people responded to combined treatment with atezolizumab (MPDL3280A) and chemotherapy in this early lung cancer study,’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. ‘This result indicates that combinations may provide a way to extend the benefits of atezolizumab to a wider range of people, including those with low levels of PD-L1 expression.’

“Roche currently has three ongoing Phase III studies of atezolizumab in combination with chemotherapy in previously untreated advanced NSCLC.”


Roche: "Investigational Medicine Alectinib Shrank Tumours in Nearly Half of People with Specific Type of Lung Cancer"

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from two pivotal studies (NP28673 and NP28761) that showed alectinib, its oral investigational anaplastic lymphoma kinase inhibitor (ALKi), shrank tumours (overall response rate; ORR: 50% and 47.8%, respectively) in people with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) whose disease had progressed following treatment with crizotinib. In addition, alectinib was shown to shrink tumours in people whose cancer had spread to the central nervous system (CNS) (CNS ORR: 57.1% and 68.8%, respectively). Additionally, people whose tumours shrank in response to alectinib continued to respond for a median of 11.2 and 7.5 months, respectively (duration of response; DOR). Alectinib demonstrated a safety profile consistent with that observed in previous studies. The most common adverse events (Grade 3 or higher occurring in at least 2% of people) were an increase in muscle enzymes (increased blood levels of creatine phosphokinase), increased liver enzymes and shortness of breath (dyspnea).1,2

“ ‘Cancer spreads to the brain in about half of people with ALK-positive lung cancer, and these studies suggest that alectinib can shrink tumours in people with this difficult-to-treat disease,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. ‘We plan to submit these data to the FDA this year to support alectinib as a potential new option for people whose advanced ALK-positive lung cancer progressed on crizotinib.’ “


Roche: "MPDL3280A Doubled the Likelihood of Survival Compared with Chemotherapy in People with a Specific Type of Lung Cancer"

“Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from a global, randomised Phase II study (POPLAR) in people with previously treated NSCLC. The study showed the investigational cancer immunotherapy MPDL3280A (anti-PDL1) doubled the likelihood of survival (overall survival [OS]; HR=0.47) in people whose cancer expressed the highest levels of PD-L1 (programmed death ligand-1) compared with docetaxel chemotherapy. An improvement in survival was also observed in people who had medium and high (HR=0.56) or any level of PD-L1 expression (HR=0.63), as characterised by a test being developed by Roche. MPDL3280A was generally well tolerated and adverse events were consistent with what has been previously reported for MPDL3280A in NSCLC. Updated results will be presented in an oral session at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO).

“ ‘In our study of MPDL3280A in previously treated lung cancer, the amount of PD-L1 expressed by a person’s cancer correlated with improvement in survival,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. ‘The goal of PD-L1 as a biomarker is to identify people most likely to experience improved overall survival with MPDL3280A alone and which people may be appropriate candidates for a combination of medicines.’ “


Roche Lung-Cancer Drug Doubles Survival Rate in Trial

“Roche Holding AG’s experimental immunotherapy for lung cancer doubled the likelihood of survival for some patients in a study, advancing development of a medicine that may help the Swiss drugmaker compete with Bristol-Myers Squibb Co. and Merck & Co.

“In a mid-stage trial among 287 patients with non-small-cell lung cancer, those who received Roche’s MPDL3280A were as much as 53 percent less likely to die during the testing period than those who received an older chemotherapy drug, according to a summary of the results distributed Wednesday by the American Society of Clinical Oncology.

“The drug harnesses the immune system to attack cancer, part of a new category of therapies that may become a $31 billion market by 2020, according to Goldman Sachs Group Inc. Roche is testing its drug in combination with other cancer therapies and plans to submit it for U.S. regulatory approval next year, said Sandra Horning, Roche’s chief medical officer.

“ ‘Roche comes out shining,’ Jeffrey Holford, an analyst at Jefferies International Ltd., said in a note to investors. ‘We continue to expect an imminent filing’ to regulators.”


UPDATE 1-Novartis Works with Bristol-Myers Squibb to Test Lung Cancer Drugs

The gist: Combining existing drugs can sometimes result in new, more effective cancer treatments. As we posted on our Need to Know blog today, lung cancer researchers are testing drug combinations that involve immunotherapies—treatments that boost the immune system to fight cancer. Now, two drug companies have announced that they will be testing combinations of their lung cancer drugs. An immunotherapy drug called Opdivo will be combined with targeted drugs. The combinations will be tested in clinical trials with volunteer patients who have late-stage non-small cell lung cancer (NSCLC). It is hoped that the combinations will work better than any of the drugs alone.

“Swiss pharma group Novartis AG said on Monday it would work with Bristol-Myers Squibb Co to test the U.S. drugmaker’s immuno-oncology drug Opdivo in combination with three of its own experimental lung cancer drugs.

“The clinical collaboration will help Novartis advance its efforts in the field of immunotherapy, one of the hottest areas in biotech right now, following the acquisition of CoStim Pharmaceuticals Inc this year, the drugmaker said.

“Novartis currently lags rivals such as Roche, Merck , AstraZeneca and Bristol-Myers in the race to develop immunotherapies – drugs that fight cancer by harnessing the body’s immune system.

“The two companies will test the combination of three molecularly targeted compounds with Bristol-Myers’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in phase I and II studies, Novartis said, adding it would conduct both studies.

” ‘Preclinical data suggests that combining molecularly targeted agents with immunotherapies such as nivolumab may have synergistic effects and lead to better outcomes for patients,’ Alessandro Riva, global head of Novartis oncology development and medical affairs, said in the statement.”


Roche Drugs Shown Effective in Breast and Skin Cancers

The gist: Drug company giant Roche is mixing drugs in new combinations to provide melanoma and breast cancer patients with potential new treatments. This article outlines the company’s endeavors.

“Mixing drugs in various combinations has given Roche Holding AG (ROG) effective new treatments for skin and breast cancer strains.

“Combining Zelboraf, a melanoma drug now on the market, with experimental cobimetinib showed significant improvement over Zelboraf alone, according to data presented today at the European Society for Medical Oncology’s annual meeting in Madrid.

“Roche said yesterday that a combination of two breast cancer drugs, plus chemotherapy, could add almost 16 months to the lives of a class of patients. Roche today also reported data from an early-stage study of its MPDL3280A immune therapy treatment in bladder cancer which showed a 52 percent response rate. If successfully developed, the drug will be the first new treatment for bladder cancer in 30 years, the Basel, Switzerland-based company said.

“ ‘This is a good meeting for Roche,’ said Asthika Goonewardene, an analyst with Bloomberg Intelligence. ‘They’re firing in three different areas.'”


Roche Says Avastin Prolongs Life in Breast Cancer Study

“Swiss drugmaker Roche said its cancer drug Avastin helped women with a common form of breast cancer live longer without their disease worsening, when used in combination with chemotherapy drug Xeloda.

“Results of a Phase III study involving 185 patients with HER2-negative metastatic breast cancer found those treated with both drugs saw an almost threefold improvement in how long they lived without their disease getting worse compared with those taking Avastin alone.

“A second late-stage trial with 494 patients who continued treatment with Avastin and standard chemotherapy after their disease had progressed showed patients lived significantly longer without the disease getting worse compared with those treated only with chemotherapy.”

Learn more about clinical trials—research studies with volunteer patients.


Roche Lung Cancer Pill Gets Reprieve in UK Reversal

“Britain’s health cost watchdog NICE on Friday reversed an earlier decision to limit the use of Roche’s Tarceva cancer pill on the state health service in a move the drugmaker said would help around 2,000 patients a year.

“New draft guidance from the National Institute for Health and Clinical Excellence (NICE) now backs use of Tarceva for people with non-small-cell lung cancer that has progressed after chemotherapy in wider circumstances than originally suggested.”


On the Failure of Lung Cancer Drug Onartuzumab in a Phase III Clinical Trial


Most new cancer drugs fail clinical testing. Because they don’t make it to the pharmacy, we usually hear very little about them. But widespread media coverage made it hard to ignore the recent termination of a trial testing the drug onartuzumab. Details of the story raise concerns about the patient enrollment processes of some clinical trials. Continue reading…