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Oncology Highlights - March 2019

Oncology Highlights - February 2019

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

 

Publications

Brain-on-a-chip to identify effective glioblastoma treatments

Researchers have developed a 3D bioprinted model of glioblastoma. The glioblastoma-on-a-chip consists of three important components: patient-derived glioblastoma tumor cells, vascular endothelial cells, and cells that provide a structural basis for the 3D model. Together, these components replicate key clinical features of glioblastoma, including areas that receive little oxygen, which is known to play a role in resistance to certain cancer therapies. This platform may pave the way to not only predict whether a specific patient will respond to a specific therapy, but also to speeding up the discovery of new glioblastoma treatments. The study is published in Nature Biomedical Engineering. (Image source: Yi et al, NBE 2018)

Promising long term safety and efficacy of CAR-T cell therapy

A two-year follow up of large B-cell lymphoma patients treated with axicabtagene ciloleucel, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, reveals durable responses and an acceptable safety profile. CAR-T therapies consist of a patient’s own immune cells, which are engineered in the lab to attack tumor cells displaying a certain marker (or antigen - CD19 in this case). In this study, 83% of the 108 patients showed a reduction in tumor size after treatment with axicabtagene ciloleucel, while 58% percent of the 108 patients had no detectable cancer after treatment. Two years after treatment, 39% of patients still had no detectable cancer and no unexpected side effects were observed. The study is published in The Lancet Oncology.

Possible new drug combination for pancreatic cancer

Pancreatic cancer has a particularly low survival rate, largely due to its resistance to many treatments. Researchers have discovered that inhibiting two different cellular processes may be key to kill pancreatic cancer cells. Combining chloroquine, which prevents the recycling of nutrients necessary for cell survival, and VE-822, which inhibits a certain type of DNA repair process, led to significant cell killing in a panel of pancreatic cells grown in a culture dish. The combination treatment also significantly reduced tumor growth in both mouse tumors and human tumors transplanted into mice. These results suggest that the limited efficacy of chloroquine treatment in pancreatic cancer may be improved with the addition of agents that interfere with DNA repair processes. The study is published in The Lancet Oncology. (Image source: cancer.gov)

Industry

  • Flagship Pioneering closes $824M fund: Cambridge, Massachusetts-based Flagship’s new capital “Special Opportunities Fund II” tied up with a significant cash that will allow the venture group building its next generation of life sciences companies. The new fund follows a similar one, Special Opportunities Fund I, closed in 2016 at $285M. Although, typical Series A rounds raise approximately $2M to $15M, Flagship supported hundreds of millions into startups with mega-round IPOs for companies like Moderna, Rubius Therpautics and Kaleido Biosciences.
  • €2B to forward European Innovation Council (EIC): Global competition is intensifying and Europe needs to deepen its innovation and risk-taking capability to compete. That is why the Juncker Commission is introducing EIC, currently in its pilot phase, EC committing over €2B funding in 2019-2020. EIC will support bold innovators at the forefront of future: AI, Implantable devices, future tech for social experience, nanoscale science is among the thematic calls. EIC will become a full-fledged reality from 2021 under the next EU research and innovation program Horizon Europe.
  • AACR 2019: The American Association for Cancer Research (AACR) met up in Atlanta, USA, to showcase the latest advances in cancer treatment from around the world. Highlights of the meeting is covered in our latest blog.

EMA/FDA

EMA

EMA’s human medicines committee (CHMP) adopted recommendations for one new initial marketing authorization and three extensions of indication at its first meeting in Amsterdam in March 2019.

The CHMP extended the therapeutic indication for:

  • Imnovid (pomalidomide, Celgene) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior treatment regimen including lenalidomide.
  • Mozobil (plerixafor, Genyzme) in combination with G-CSF to enhance mobilization of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in Paediatric patients with lymphoma or solid malignant tumors. This immunostimulant has been previously approved for adult patients with the same indication under the orphan drug status by FDA and EMA.
  • Revlimid (lenalidomide, Celgene) as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone for the treatment of adult patients with previously untreated MM who are not eligible for transplant. This thalidomide derivative is already approved as monotherapy for MM and has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS).

FDA

The FDA granted approval for:

  • Tecentriq (atezolizumab, Roche) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Approval was based on IMpower133 in which the PD-L1 inhibitor combination with carboplatin showed better OS and PFS. This is the first cancer immunotherapy to be approved as initial therapy in this tumor type since 20 years.
  • Tecentriq (atezolizumab, Roche) for patients with PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer. Approval is based on IMpower130 trial in which PD-L1 positive population was stratified with VENTANA PD-L1 (SP142) Assay (also approved by FDA as companion diagnostic). As the PD-L1 space is very crowded, Roche is carving a niche with unconquered indications.