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Lilly's Cyramza Successful in Phase III First-Line NSCLC Study

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Eli Lilly and Company (LLY - Free Report) announced encouraging data from a phase III study – RELAY – evaluating cancer drug, CYRAMZA, in combination with Roche’s (RHHBY - Free Report) Tarceva (erlotinib) in first-line metastatic non-small cell lung cancer (“NSCLC”) patients with EGFR mutations. Data from the study showed that the combination therapy met the primary endpoint of improving progression free survival (“PFS”), significantly delaying disease progression compared to placebo.

Cyramza is currently approved in combination with chemotherapy, docetaxel, for second-line metastatic NSCLC. The drug is also approved for second-line gastric and colorectal cancer. Lilly is also seeking approval of the drug for second-line hepatocellular carcinoma or liver cancer.

The successful completion of the RELAY study may get approval for Cyramza’s first indication in previously untreated patient population. The company plans to submit regulatory applications for the drug’s label expansion in first-line NSCLC in mid-2019. Please note that first-line NSCLC has a significant market opportunity due to large number of patients. However, the segment is getting competitive with new approvals and several therapies under development.

In December 2018, the FDA approved a combination of Roche’s Tecentriq in combination with Avastin and chemotherapy for first-line metastatic non-squamous NSCLC. Earlier in October, Merck’s (MRK - Free Report) Keytruda in combination with chemotherapy received approval for treating first-line metastatic squamous NSCLC. Pfizer’s (PFE - Free Report) Vizimpro was approved in September for metastatic NSCLC with EGFR mutation. Several other therapies were approved for NSCLC related indications in 2018.

So far this year, Lilly’s shares have gained 6.7% compared with the industry’s rise of 2.5%.


Cyramza generated revenues of $821.4 million in 2018, recording a year-over-year increase of 8%. Meanwhile, Cyramza is being evaluated in several studies as monotherapy or in combination with other therapies for additional indications.

Apart from Cyramza, Lilly is also developing a wide range of therapies for several indications. The company has launched 10 new drugs since 2014, which have shown strong sales growth. It expects to launch another new 10 drugs in the next five years. If the upcoming launches can replicate the impressive performance of the new marketed drugs, the company will be well poised for growth in the long term.

Lilly’s marketed portfolio has diversified products including multiple oncology drugs as well as drugs for other non-cancer diseases. The company’s revenues are expected to be driven by strong demand for its new drugs including Trulicity, Jardiance, Taltz, Verzenio and Emgality. However, several legacy drugs are facing generic competition. Moreover, competition from other branded drugs as well as pricing pressure prevailing in the U.S. markets will also unfavorably impact the company’s top line in 2019.

Zacks Rank

Lilly currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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