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Oncology Highlights - January 2018

Oncology Highlights - January 2018

Stay informed on the latest news within oncology drug development! Subscribe to our newsletter to keep up to date with last month’s science, industry and regulatory oncology highlights!

Enjoy reading! - The SMS-oncology team

World Cancer Day 4 Feb: We can. I can.

Since three years, World Cancer Day (WCD) on 4 February aims to raise awareness and to save lives with prevention and education. Initiative adopts a united commitment to fight against the cancer under the UN’s Sustainable Development Goals (SDGs). This year’s tagline “We can. I can.” aimed to emphasize the collective responsibility to reduce the preventable deaths. Currently, 8.8 million people die from cancer worldwide every year, out of which, 4 million people die prematurely (aged 30 to 69 years). The WCD’s primary objective is to get as many people as possible around the globe to talk about cancer on 4 February. One positive initiative comes through the Dutch charity group lookgoodfeelbetter, they teamed up with various beauticians around the Netherlands who are offering free beauty/ pampering treatments to patients with cancer (both women and men)– for the whole month of February. For more information, please see their website: http://www.lookgoodfeelbetter.nl/. You can also get involved in World Cancer Day with posting in social media with #WorldCancerDay and #WeCanICan or simply sharing the material posted in worldcancerday.org/materials.

Publications

One test to SEEK it all

Majority of cancer deaths can be prevented by surgical removal if diagnosed in non-metastasized, early stage. However, current diagnostic methods are limited, and lacks sensitivity for detecting low rate mutations (<1 mutations per ml of plasma) of circulating tumor (CT) DNA in early stage patients. Researcher’s in Johns Hopkins Kimmel Cancer Center developed a noninvasive, multi-analyte blood test that detects and localizes eight common cancer types: CancerSEEK; this test can achieve both a greater sensitivity for CT mutation detection and diagnosis of the tumor tissue origin which is not possible with regular liquid biopsies. After careful selection of biomarkers, CancerSEEK test aimed at measuring the levels of as little as 8 proteins associated with tumor types and only 16 CT mutations. The method detects the most prevalent cancer types: ovarian, liver, stomach, pancreas, esophagus, colorectum, lung, or breast with a median of 70% sensitivity according to the research conducted in 1005 non-metastatic patients. The results lay the foundation of long awaited “wonder” test to seek cancer before cancer seeks us, however test will require further optimization to be safely used in standard practice. The findings were published online by Science.

 

First clinical trial with CRISPR is ready to kick-off in US and Europe

China has taken the flag to be the first country to involve CRISPR in clinical trials and reports suggest that already 86 patients have undergone the treatment since 2016. China’s rapid advancement is the result of more relaxed regulations, and finally this year gene editing studies are planned to start in Europe and US. Last December, CRISPR therapeutics, a Swiss biotech company filed an application for a Europe-based Phase I/II trial in patients with β thalassemia. Subsequently, this January, investigators at the University of Pennsylvania announced the plans for a cancer immunotherapy clinical trial with CRISPR. This first gene-editing study (NY-ESO-1-redirected CRISPR Edited T Cells) in US will be targeting three different indications: multiple myeloma, sarcoma, and melanoma. In this study, investigators plan to modify TCR and PD-1 genes of autologous T cells of 18 patients via CRISPR editing instead of viral vectors. Project was announced on MIT Technology Review reports.

Cancer death rate has fallen in the last decade in the US

The recent Cancer Statistics 2018 report published by American Cancer Society indicated that the overall cancer death rate has dropped continuously with a significant 26% between the years 1991 to 2015 in United States. The actual number translates to 2.378.600 gained lives during this time and celebrated as good news with the start of 2018. It is the only disease from the top 10 killers to decline over the past decade. But is it really positive news other than some statistical number crunching? The declining smoking rates, early detection and prevention are the main reasons behind the fewer deaths explains Ahmedin Jemal, vice president for surveillance and health services research in ACS. Although, report reveals the significant gaps due to wealth inequality, racial groups, obesity and access to treatment for mortality, some cancers became less mortal such as breast cancer (drop of 39%, from 1989 to 2015), and prostate cancer (drop of 52%, from 1993 and 2015). The report implies the decline can be accelerated with addressing smoking, obesity and prevention issues in health policies.

Industry

2018 Biotech M&A peak: Merger January totals to $50 Billion

The total value of biotech deals in the first couple of weeks of 2018 has almost surpassed the half year of 2017. Earlier this month Celgene acquired the Seattle-based Juno Therapeutics with the biggest deal in its history for $9 Billion, to gain full access to CAR-T oncology pipeline, and specifically to JCAR017. Novartis strengthened its nuclear medicine platform with $3.9 Billion buy of French cancer specialist Advanced Accelerator Applications (AAA) which has now both EMA and FDA marketing authorizations for its flagship drug Lutathera that targets gastroenteropancreatic neuroendocrine tumors (GEP-NETs). It is the first Peptide Receptor Radionuclide Therapy (PRRT) that’s has ever been approved in the US. French giant Sanofi signed two significant deals this month with acquisition of hemophilia drugmaker Bioverativ for $11.6 Billion and a winning buy of Ablynx for $4.8 Billion over Novo Nordisk’s offer. Latest deal came from Varian Medical Systems’ acquisition Sirtex for $1.3 Billion. Liver cancer specialist Sirtex’s lead product SIR-Sphere -radioactive beads- is likely to have a bigger market in Asia-Pacific region, which accounts for 80% of worlds primary liver cancer. In 2018, it is expected that we will be seeing more M&As as pharma and biotech face maturing markets therefore in need of new growth opportunities. RBC Capital Markets survey indicates further deals with Clovis Oncology, Sage Therapeutics, Puma Biotechnology, Bluebird Bio.

EMA/FDA

EMA
EMA has not announced any approvals or recommendations for new oncology drugs in January 2018. An application to extend the use of Opdivo (nivolumab) to treat colorectal cancer has been withdrawn.

  
FDA

The Food and Drug Administration adopted a positive opinion for:

  • Afatinib (Gilotrif, Boehringer Ingelheim) as a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations. The tyrosine kinase inhibitor irreveresibly inhibits Her2 and EGFR kinases and blocks angiogenesis.

  • Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for the treatment somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The radiolabeled somatostatin analog initially gained the marketing authorization by European Commission in September 2017 and is the first PRRT therapy approved in the US.

  • Olaparib (Lynparza, AstraZeneca) for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy. The PARP inhibitor is the first FDA approved targeted therapeutic for BRCA-mutant breast cancer.

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