Lilly's Cyramza hits mark in first-line lung cancer trial

Eli Lilly has produced phase 3 data that supports use of its Cyramza combined with Roche's Tarceva in first-line non-small cell lung cancer with EGFR mutations, paving the way for filings with regulators later this year.

Already approved in second-line lung cancer and gastric and stomach cancers, Lilly is looking for further uses for the drug that blocks blood supply to tumours.

Lilly said results from the phase 3 study showed Cyramza in combination with Tarceva (erlotinib) met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement in the time patients lived without their cancer growing or spreading after starting treatment.

Lilly said it plans to start filing with global regulators such as the Food and Drug Administration (FDA), and the European Medicines Agency (EMA), in mid-2019.

This lines the drug up for a showdown with AstraZeneca’s Tagrisso (osimertinib), which was FDA-approved in this indication in April last year.

There are also a host of older EGFR inhibitor drugs approved in this use such as AZ's Iressa (gefitinib) and Tarceva - and it remains to be seen whether the improved performance of the Cyramza combination compared with Tarceva alone will be enough to convince doctors to prescribe it.

Lilly plans to announce details of the trial at a forthcoming medical conference, which should give a steer about whether doctors are impressed.

The phase 3 global randomised trial is testing Cyramza in combination with Tarceva compared with placebo and Tarceva, in untreated patients with metastatic non-small cell lung cancer whose tumours have activating EGFR mutations.

The safety profile observed in the RELAY study was consistent with what has been previously observed for Cyramza in phase 3 clinical trials and the established safety profile of Tarceva.

The most common serious adverse events occurring at a higher rate on the treatment arm compared with the control arm were hypertension, an acne-like rash, and diarrhoea.

First approved in 2014 in stomach cancer, Cyramza is one of the company’s most successful drugs that have been launched in the last five years.

Sales for full year 2018 were just over $821 million, an increase of 8% compared with full year 2017.

As well as the new first-line lung cancer indication, Lilly has also filed results of the REACH-2 study with regulators in the US, EU and Japan, which the company hopes will support use in certain patients with second-line liver cancer.

However competition in this indication will be tough, as Cyramza will be facing off against established therapies such as Bayer's Stivarga (regorafenib), and Bristol-Myers Squibb's Opdivo (nivolumab).