A combination therapy of ilixadencel plus sunitinib (Sutent) achieved complete tumor responses in patients with metastatic renal cell carcinoma (RCC), according to new data from a phase 2 clinical study.

Approximately 273,000 new cases of RCC are diagnosed worldwide each year. There is a need for alternative treatment options for these patients, as many of the available targeted therapies offer only a short duration of effect with limited survival gain.

Ilixadencel is an off-the-shelf cancer immune primer developed for the treatment of solid tumors. The MERECA clinical trial evaluated the therapeutic impact of combining ilixadencel with sunitinib in advanced kidney cancer.

For the study, 88 newly-diagnosed, intermediate- and poor-prognosis patients with metastatic RCC were enrolled. Patients received either 2 intratumoral doses of ilixadencel before nephrectomy and subsequent treatment with sunitinib or sunitinib monotherapy post-nephrectomy.

According to the study, a total of 70 patients enrolled in the study were evaluable for overall response. The data demonstrated a complete tumor response in 5 of 45 patients who received ilixadencel (11%) and 1 of 25 patients in the control group (4%). Complete responses were defined as eradication of the cancerous tumor and no further evidence of disease, without ilixadencel adding toxicity. Because of extended patient survival above 60% in both study arms at 18 months, median overall survival has not yet been reached.

Overall, the safety and tolerability results were similar in the 2 treatment groups and in line with previous positive safety data for ilixadencel in clinical trials.

“As a clinical oncologist specialized in treating kidney cancer patients, the prospect of an immune primer that can support the achievement of complete responses in advanced-stage patients with a positive tolerability and safety profile is extremely exciting, especially in an indication in which complete responses are rare,” study investigator Magnus Lindskog, PhD, associate professor at Uppsala University Hospital, said in a statement. “If this response rate can be confirmed in a larger pivotal trial, it would represent a major step forward for the treatment of kidney cancer patients.”

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Merck & Co/MSD’s Keytruda has added first-line kidney cancer treatment to its ever-lengthening list of approved uses in the EU.

The latest approval, which was also granted by the US FDA earlier this year, covers the use of PD-1 inhibitor Keytruda alongside Pfizer’s targeted drug Inlyta (axitinib) in previously untreated patients with renal cell carcinoma (RCC) – the most common form of kidney cancer.

RCC is shaping up to be another lucrative new market for Keytruda, which is already approved for several different types of cancer and currently dominates the lung cancer market.

Keytruda has been given the nod by the European Commission in RCC on the strength of the phase 3 KEYNOTE-426 trial, which showed that the combination with Inlyta reduced the risk of death by 47% compared to Pfizer’s older targeted drug Sutent (sunitinib).

The new approval opens another front in Keytruda’s bid to displace the combination of BMS’ PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab) in first-line RCC, which was approved in the EU in January and in the US last year and is now considered a go-to regimen for first-line patients.

RCC is thought to have underpinned a lot of Opdivo’s recent sales growth, along with the checkpoint inhibitor’s use in adjuvant melanoma.

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