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Lilly Initiates Phase III Lung Cancer Study on RET Inhibitor

Zacks Equity Research

Eli Lilly and Company LLY initiated a phase III LIBRETTO-431 study (NCT04194944) on its oral RET inhibitor, selpercatinib (LOXO-292), in treatment-naïve, RET fusion-positive non-small cell lung cancer (NSCLC) patients. The study aims to enroll 400 patients with advanced or metastatic RET fusion-positive NSCLC, who have received no prior systemic therapy for metastatic disease.

The stock has gained 4.4% so far this year compared with the industry’s growth of 8.4%.

The patients enrolled in the study will be randomized to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without Merck and Co.’s (MRK) Keytruda as initial treatment of their advanced or metastatic RET fusion-positive NSCLC. The study’s primary endpoint is progression-free survival (PFS) and secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR) and intracranial ORR.

The company is initiating the study after it announced positive results from the phase I/II registrational study — LIBRETTO-001 in September 2019. The study showed that selpercatinib demonstrated a 68% ORR or shrinkage in tumor size in heavily pretreated patients with RET fusion-positive NSCLC. Meanwhile, the median DoR was 20.3 months and median PFS was 18.4 months in the selpercatinib arm.

Notably, selpercatinib was added to Lilly’s portfolio with the February-2019 acquisition of Loxo Oncology, which broadened its scope in precision medicines. Precision medicines are an emerging approach to cancer treatment, which tailors a regime depending on the patient’s genetic, environmental and lifestyle factors. Many industry players are adopting this approach to bring new cancer treatments.

One such company is Blueprint Medicines Corp. BPMC, which is developing transformational precision medicines to address patients with genomically defined cancers and rare diseases. The company is developing pralsetinib for treating patients with RET-fusion NSCLC previously treated with platinum-based chemotherapy  and plans to submit an NDA for the same in the first quarter of 2020.

 

Eli Lilly and Company Price

 

Eli Lilly and Company Price

Eli Lilly and Company price | Eli Lilly and Company Quote

Zacks Rank & Stocks to Consider

Lilly currently carries a Zacks Rank #3 (Hold).

A few similar-ranked stocks in the large cap pharma sector are GlaxoSmithKline plc. GSK and Merck & Co. Inc. MRK, both carrying Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

GlaxoSmithKline’s earnings per share estimates have increased from $2.98 to $3.17 for 2019 and from $3.01 to $3.10 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23%, on average.

Merck’s earnings per share estimates have increased from $4.91 to $5.15 for 2019 and from $5.37 to $5.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 12.51%, on average.

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