With Alimta patent cliff looming, Lilly plots stronger foothold in frontline NSCLC with Cyramza

With Lilly’s foothold in the non-small cell lung cancer (NSCLC) field weakening as its Alimta franchise marches toward a patent cliff, another cancer treatment manufactured by the drugmaker could be used as a frontline treatment in the lucrative market. On Tuesday, the Indianapolis company said its drug, Cyramza, in combination with Roche’s Tarceva, helped stem the spread and growth of cancer as an initial treatment in certain patients with metastatic NSCLC in a pivotal study.

Cyramza is already approved for use in combination with the chemotherapy drug docetaxel in metastatic NSCLC patients whose cancer had progressed on or after prior platinum-based chemotherapy. This Phase III 449-patient trial, called RELAY, tested the Cyramza+Tarceva combo in previously untreated patients with EGFR-positive mutations.

Detailed results will be provided at a future medical meeting, Lilly said, adding that it was preparing for global regulatory marketing submissions in mid-2019.

About 228,150 of new cases of lung cancer are expected in the United States this year, the American Cancer Society estimates. It is a deadly disease — and most patients undergo several therapeutic regimens to extend their survival. Tyrosine kinase inhibitors (TKIs) are the current standard treatment option for EGFR-mutated NSCLC, and Tarceva is considered standard-of-care for this type of lung cancer, Lilly said.

Maura Dickler

“Despite recent treatment advances in metastatic EGFR-mutated non-small cell lung cancer, prognosis remains poor and there is an ongoing need for additional first-line treatment options to help patients with this deadly disease,” said Maura Dickler, vice president of late phase development, Lilly Oncology.

Cyramza, which is also approved for second-line gastric and colorectal cancer, generated about $822 million last year and is currently under review as a second-line treatment for patients with hepatocellular carcinoma.

In January, Lilly $LLY agreed to pay $8 billion for Loxo Oncology $LOXO, which managed to get a drug — a site-agnostic cancer treatment — approved in a relatively quick 5 years. But the main attraction for Lilly is Loxo’s experimental LOXO-292, which has significant commercial potential in patients with NSCLC. Upon the announcement, Stifel analysts suggested the transaction was strategic considering Alimta has lost patent protection in parts of Europe and is thought to soon be losing US exclusivity: “(A)pproximately 55-60% of the end-market for LOXO-292 – the valuation centerpiece of this transaction per LLY – is represented by RET-fusion NSCLC and thus represents a readily-accessible opportunity requiring minimal infrastructure build-out.”

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