AZ Cancer Immunotherapy Combo Impresses in Lung Cancer Trial

“Two immuno-oncology drugs in development at AstraZeneca (AZ) have shown potential as a dual therapy for non-small cell lung cancer, according to a new study.

“The phase II trial – reported in Lancet Oncology – found that combining anti-PD-L1 antibody durvalumab with anti-CTLA-4 antibody tremelimumab achieved an overall response rate (ORR) of 23%, significantly higher than has previously been seen with durvalumab alone in this setting.

“The trial was small and focused primarily on safety, but the preliminary efficacy signal – albeit in just 26 patients – is encouraging, according to an editorial accompanying the study by Edward Garon of the David Geffen School of Medicine at the University of California, Los Angeles.”

AstraZeneca Drug Combination on Track to Fight Lung Cancer

“A closely watched immune system-boosting drug cocktail from Britain’s AstraZeneca shows promise in advanced lung cancer, despite adverse side effects in a number of patients.

“Researchers said on Wednesday that the combination of the experimental drugs MEDI4736 and tremelimumab had ‘a manageable safety profile with evidence of clinical activity, including in PD-L1 negative disease’.

“The update was provided in a scientific summary, or abstract, released ahead of the annual meeting of the American Society of Clinical Oncology (ASCO) later this month.

“MEDI4736 is an anti-PD-L1 therapy, which works by stopping a tumor’s ability to evade the body’s defenses. Tremelimumab blocks a different molecule, CTLA-4, that also keeps the immune system from attacking cancer.”

AstraZeneca-Novartis Three-Drug Melanoma Treatment Found Safe

“A first-of-its-kind combination of three drugs to treat a deadly form of skin cancer can be taken safely, passing the first hurdle to regulatory approval for a potentially long-lasting treatment.

“The treatment was tested in an early-stage trial that was a collaboration between AstraZeneca Plc and Novartis AG. Researchers combined two drugs, dabrafenib and trametinib — a so-called doublet therapy that has been proven effective in targeting melanomas with mutations in the BRAF gene — with an immune system-based treatment that may prevent the disease from relapsing.

“Dabrafenib, sold as Tafinlar, and trametinib, sold as Mekinist, were developed by GlaxoSmithKline Plc and acquired by Novartis in March. The immune therapy drug, MEDI4736, is being developed by AstraZeneca.

“Melanoma is a rare but deadly form of skin cancer for which a number of drugs have been approved in recent years. Among them are BRAF inhibitors like dabrafenib, which target mutations found in about half of all melanoma patients, as well as immune therapies like Bristol-Myers Squibb Co.’s Yervoy, which unleash the body’s own immune system. Because the immune system can be trained, those therapies may be more durable than other forms of treatment.”

AstraZeneca's Olaparib May Also Work in Prostate Cancer: Expert

“AstraZeneca’s new cancer drug olaparib, which won a green light from European regulators last month for inherited ovarian cancer, could also be used much more widely to treat prostate cancer, according to a leading oncologist.

“Johann de Bono, professor of experimental cancer therapeutics at the Institute of Cancer Research in London, told a conference on Tuesday the drug had produced “encouraging” preliminary results in clinical tests against prostate cancer.

“Olaparib works by blocking an enzyme involved in cell repair and is designed for patients with hereditary BRCA gene mutations, which are also found in breast and gastric cancer.

“While AstraZeneca believes the drug has the potential to sell $2 billion a year, the company has so far only talked about its promise in ovarian, breast and gastric cancer.

“However, de Bono told the National Cancer Research Institute that olaparib might also work in patients who have not inherited BRCA mutations but do carry mutations to DNA repair genes within their tumors.

To test the theory, de Bono and colleagues have assessed olaparib in advanced prostate cancer tests, including a mid-stage Phase II clinical trial, the first part of which has now closed.

“ ‘Although PARP inhibitors like olaparib have generally been trailed in women with inherited BRCA mutations, these exciting new trials could give them a whole other lease of life in advanced prostate cancer and other tumors with DNA repair mutations,’ de Bono said.

” ‘It is too early to say whether they will prove to be beneficial in prostate cancer but the initial results from our preliminary trials have been encouraging.’ “

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.”

UPDATE 1-Early Data Promising for AstraZeneca Cancer Drug Combination

The gist: Researchers found promising results for a new lung cancer treatment in a clinical trial—a research study with volunteer patients. The immunotherapy treatment combines the drugs MEDI4736 and tremelimumab. It is meant to boost a patient’s own immune system to fight cancer.

“Early results for a closely watched cancer drug combination from AstraZeneca that boosts the immune system show the cocktail is promising, though limited patient numbers mean the data is far from conclusive.

“The British drugmaker, which fended off a $118 billion takeover bid from Pfizer in May in part by talking up its cancer drug prospects, has high hopes for the combination of two experimental drugs known as MEDI4736 and tremelimumab.

“The company is still exploring a range of doses, so testing of the drugs in lung cancer is taking time to yield results and data on only two dozen patients was reported at the European Society for Medical Oncology (ESMO) congress on Saturday.

“Chief Executive Pascal Soriot had said earlier this month that the ESMO numbers would be limited.

“Still, researcher Scott Antonia of the Moffitt Cancer Center in Florida said the early signals were encouraging, both for safety and efficacy. ‘It looks very, very promising, he said.

“AstraZeneca expects to have more definitive results later this year and also plans to start a pivotal clinical trial with the combination either late this year or at the start of 2015.”

AstraZeneca Seeking to Get Cancer Drugs to Patients Early

“British patients could benefit from AstraZeneca’s promising new cancer drugs well before they complete clinical testing, the Telegraph can reveal.

“Pascal Soriot, chief executive, told the Telegraph he was looking to make two of Astra’s most eye-catching cancer drugs widely available to patients as soon as possible.

“Britain’s recently launched early access to medicines scheme, which aims to get drugs to patients years earlier than the normal regulatory process allows, is among the programmes in Mr Soriot’s sights. The US, France and Japan have also established pathways to fast-track promising new drugs to patients ahead of final regulatory approval.”

Funding Strategy Needed to Support EGFR Mutation Testing in Canada

Funding represents a decisive barrier to the nationwide implementation of genetic testing for a key lung cancer mutation in Canada, a recent study finds. Patients with non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene frequently benefit from treatment with EGFR inhibitors. AstraZeneca, makers of the EGFR inhibitor gefinitinb (Iressa), reimbursed Canadian laboratories for offering EGFR mutation testing to patients with advanced non-squamous NSCLC for 12 months. EGFR mutation testing was rapidly adopted into routine clinical practice in Canada. However, testing rates dropped sharply once the reimbursement program ended. Researchers conclude that a national strategy is needed to provide resources for continued EGFR testing.