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Oncology Highlights - October 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


Niraparib increases PFS in advanced ovarian cancer: Due to their proven efficacy in patients with recurrent cancers, polyADP-ribose polymerase (PARP) inhibitors such as niraparib are gaining increasing attention. In this randomized, double-blind, phase III trial the efficacy of niraparib in patients with newly diagnosed ovarian cancer responsive to first-line platinum-based chemotherapy was evaluated. In patients with homologous-recombination deficiency (50.9%) and the overall population, niraparib vs placebo substantially prolonged the median progression-free survival (PFS; 21.9 vs 10.4 and 13.8 vs 8.2 months, respectively; p<0.001). These results, together with the satisfactory safety profile observed, make niraparib an attractive therapy for these patients. Results were published in the New England Journal of Medicine

Ramucirumab and erlotinib increase PFS in metastatic NSCLC: While dual blockade of the vascular endothelial growth factor (VEGF) and epidermal growth factor (EGFR) pathways is supported by preclinical data, the approach is not widely implemented in the clinics. The unique worldwide, double-blind, phase III RELAY trial, assessing the efficacy of ramucirumab (VEGF2 antagonist) plus erlotinib (EGFR inhibitor), reported a significantly longer PFS in patients receiving combined treatment vs erlotinib alone (19.4 vs 12.4 months; p<0.0001). The safety profile of the combined treatment was consistent with those of the individual compounds. Taken together, these results highlight an exciting new treatment option for EGFR-mutated metastatic NSCLC. Results were published in The Lancet Oncology.


  • Theragnostics and GE Healthcare enter global partnership for the new prostate-specific membrane antigen imaging agent GalliProst. Theragnostics will lead tracer development, while GE Healthcare will lead all pre-approval commercial preparations and subsequent commercial activities. Financial agreements were not disclosed.
  • ImaginAb enters multi-party collaboration with AstraZeneca, Pfizer, and Takeda for the clinical development of its CD8 ImmunoPET technology, able to quantitatively assess the immunological status of each cancer lesion of a patient. The collaborators will guide ImaginAb’s clinical trial evaluating the technology’s utility/value, as well as benefit from potential future gains. Financial agreements were not disclosed.
  • Cato Research announces merger with SMS-oncology to bolster its portfolio of global solutions to support small and midsize biotech with personalized, high tough full-service CRO services and regulatory expertise dedicated to difficult areas as (immuno-) oncology, orphan diseases and ATMPs. The combined company will transition to the new name, CATO SMS, in the coming year.


The Committee for Medical Products for Human Use (CHMP) adopted a positive opinion (extension of indications) for:

  • Darzalex (daratumumab, Janssen), in combination with lenalidomide and dexamethasone, for frontline multiple myeloma in newly diagnosed patients who are ineligible for autologous stem cell transplant. Approval is based on data of phase III ALCYONE study in which a reduced risk of disease progression or death by 50% was shown. Genmab receives a USD 7 million milestone payment from Janssen under their license agreement.
  • Keytruda (pembrolizumab, Merck), included in two new regimens as frontline treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma.


The FDA granted approval/clearance for:

  • Zejula (niraparib, Tesaro), an oral, once-daily poly (ADP-ribose) polymerase inhibitor, for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with ≥3 prior chemotherapies and whose cancer is homologous recombination deficiency (HRD)-positive. This is based on the multicenter QUADRA phase II trial, which reported an ORR of 24% in the FDA-indicated population. 
  • myChoiceCDx (Myriad), for use by healthcare professionals as a companion diagnostic to identify women with advanced ovarian cancer who are candidates for niraparib in the late-line treatment setting. It’s the first and only tumor test that determines homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants with comprehensive assessment of genomic instability using three critical biomarkers: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions.
  • CivaDerm (CivaTech), a polymer-encapsulated brachytherapy device designed for intra-operative/surface radiation to treat skin cancer and other lesions. CivaDerm’s gold shielding design allows only one side of the device to be active. This is the only product of its type FDA-approved.

In addition to approvals, FDA granted breakthrough therapy/device designation to several products to progress their development. These include:

  • Cotellic (cobimetinib, Genentech), an oral MEK1/2 inhibitor previously approved for melanoma, for treatment of patients with histiocytic neoplasms. The designation was based on the cobimetinib phase II trial published in Nature earlier this year, which reported an overall response rate (ORR) of 89%, and a 94% progression-free survival (PFS) rate at 12 months.
  • Zejula (niraparib (Janssen), for patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer with disease progression after taxanes and androgen receptor-targeted therapy. The designation was based on the GALAHAD phase II trial, whose results reported an ORR of 41% and a complete response rate of 63% after a median follow-up of 7.3 months. Janssen entered a worldwide collaboration and license agreement with Tesaro for exclusive rights to nirapinib in prostate cancer.


FDA finalizes guidance on IVD use in cancer trials: Recommendations describe a streamlined submission process for assessing whether the sponsor needs to file an investigational device exemption (IDE). Several changes were brought to the initial draft guidance to address feedback of lobby companies such as AdvaMed and PhRMA. These include: advice for managing clinical trials using multiple investigational in vitro diagnostics (IVDs), updates in the information required for an investigational new drug (IND) submission, and requirements to include IVD and patient population descriptions. Sponsors can now assess whether an IVD is considered to be a significant/non-significant risk or exempt from IDE requirements, within 30 days. For significant risk IVDs, sponsors will need to file an IDE in addition to the usual IND.