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Pfizer’s plans for Inlyta go awry with failed adjuvant trial

Interim data suggested there was no improvement on disease-free survival compared to placebo


Pfizer’s hopes of reversing the decline of its renal cell carcinoma (RCC) treatment Inlyta have taken a knock with a failed phase III trial in patients with less advanced disease.

The ATLAS study was testing whether VEGF inhibitor Inlyta (axitinib) given as an adjuvant treatment after surgery to remove the tumour could improve disease-free survival compared to placebo, but has been called to a halt after an interim look at the data suggested there was no clear benefit.

Inlyta is already approved to treat RCC after failure of first-line therapy, and the company’s R&D head Mace Rothenberg said he had hoped that efficacy “would carry over to patients with earlier stage disease, where it would delay or prevent disease relapse. That goal was not achieved”.

Pfizer’s drug was a big hit in second-line RCC treatment after its approval in 2012, but failed to transfer that potential to the first-line setting after a trial pitting it against Bayer’s first-line VEGF drug Nexavar (sorafenib) failed to show any improvement in progression-free survival.

Since then, the second-line RCC sector has become increasingly crowded with Inlyta retreating in the face of competition from other drugs, notably Bristol-Myers Squibb’s immuno-oncology therapy Opdivo (nivolumab) and Exelixis’ multikinase inhibitor Cabometyx (cabozantinib) - backed by strong overall survival data - as well as Eisai’s multikinase drug Lenvima (lenvatinib).

The story can be seen in the sales figures, with the drug peaking at $430m in 2015. It’s since fallen back steadily, declining 15% to $339m last year. Moreover, Pfizer’s own first-line RCC drug - Sutent (sunitinib) - is also being challenged as the newer drugs move into the treatment-naïve setting.

Sutent sales slipped 1% last year to just over $1bn but could suffer as Opdivo and other cancer immunotherapies get approved in front-line RCC, despite Pfizer claiming FDA approval of the drug as an adjuvant therapy last November.

The failure of ATLAS means Pfizer now has a lot more riding on its JAVELIN trial of Inlyta in combination with Merck KGaA-partnered PD-L1 inhibitor Bavencio (avelumab) in first-line RCC, which is due to generate results in 2019 but will also come up against combination therapies from immuno-oncology rivals, not least Opdivo and BMS’ CTLA4 inhibitor Yervoy (ipilimumab) which is already under regulatory review for newly-diagnosed RCC patients.

JAVELIN remains on track, but the failure of the adjuvant trial also knocks back hopes that the pairing - which Pfizer chief executive Ian Read had previously described as “unique” for this type of cancer - could eventually find broader utility in RCC.

Article by
Phil Taylor

11th April 2018

From: Research



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