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Immunotherapy Plus Targeted Drug in First-Line Kidney Cancer

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Adding immunotherapy to a targeted agent significantly improved progression-free survival (PFS) when compared with a targeted agent alone in the first-line treatment of advanced renal cell carcinoma (RCC), suggests interim results from the JAVELIN Renal 101 trial.

The combination therapy, comprised of the anti-programmed cell death ligand 1 (PD-L1) drug avelumab (Bavencio, EMD Serono) and the vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) axitinib (Inlyta, Pfizer), was pitted against the current standard of care, sunitinib (Sutent, Pfizer).

The results, presented here at the European Society of Medical Oncology 2018 annual meeting, revealed that combination therapy improved median PFS by 39% in patients who tested positive for PD-L1 expression and by 31% in the overall patient population.

The objective response rate with avelumab plus axitinib was also almost more than twice that seen with sunitinib, and the combination therapy had a favorable safety profile.

Study presenter Robert J. Motzer, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, New York City, said in an ESMO press release that “the findings support the potential of avelumab plus axitinib as a new treatment approach for patients with advanced RCC.”

As this was a preliminary analysis of the JAVELIN Renal 101 study, the overall survival data are immature, although there was a signal for an increase in median overall survival, at a hazard ratio at this point of 0.79 (P = .0679)

Commenting for ESMO, Thomas Powles, MD, PhD, consultant oncologist at Barts Health NHS Trust, London, UK, described the results as “eye-catching.”

Adding a note of caution, however, Powles added: “This approach involves giving combinations of most active agents upfront; therefore, there is uncertainty around whether this will translate into a similarly impressive survival signal as seen with other immunotherapy combinations.”

For All Patients?

“The combination benefit was shown in all subgroups of patients, by independent review as well as by investigators, and whether tumor cells stained positive for PD-L1 or not,” Motzer commented.

At a press conference for the study, Motzer said that, based on their findings, “I don’t believe you need to test [PD-L1] to choose patients for this therapy.”

“It may be that…the hazard ratio is a little better in the PD-L1+ group, but I don’t think it’s required to use this medicine. I think it can be given regardless of PD-L1 status,” he said.

GDMeds, an India Pharmacy Service company


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