Lilly is gearing up to file Cyramza for first-line treatment of certain lung cancer patients, after new trial data showed that the drug significantly extended progression-free survival (PFS) in this setting.

In the Phase III RELAY study, a combination of Cyramza (ramucirumab) and erlotinib met its primary endpoint of significantly improving PFS when used as first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have activating EGFR mutations, compared to those taking erlotinib alone.

On the safety side, the most common (>5% incidence) Grade ≥3 adverse events occurring at a higher rate (≥5% difference) on the Cyramza-plus-erlotinib arm compared to the placebo-plus-erlotinib arm were hypertension, dermatitis acneiform (an acne-like rash), and diarrhea the firm said, but the firm noted that the findings were consistent with those seen in other clinical trials of the drug.

There is no cure for people with metastatic lung cancer, which is linked with low survival rates, and disease progression following acquired resistance remains a challenge.

Most patients take several lines of therapy and the therapeutic regimen prescribed for first-line treatment can impact a person's options for later lines of treatment, Lilly said, highlighting the unmet need in the field.

Tyrosine kinase inhibitors (TKIs) – such as erlotinib - are the current standard treatment option for EGFR-mutated NSCLC.

Lilly said it is excited about the results, and confirmed that it plans to initiate global regulatory submissions to expand the scope of Cyramza to include first-line NSCLC mid-year.

In the US, Cyramza is approved for use as a single agent or in combination with paclitaxel for advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma following progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy; in combination with docetaxel for metastatic non-small cell lung cancer (NSCLC) if the cancer has progressed on or after platinum-based chemotherapy; and with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.