Eli Lilly and Company's LLY oral RET inhibitor selpercatinib (LOXO-292) demonstrated a 68% objective response rate (ORR) or shrinkage in tumor size in heavily pretreated patients with RET fusion-positive non-small cell lung cancer (NSCLC).
This data was presented from a phase I/II registrational study — LIBRETTO-001 — at the World Conference on Lung Cancer (WCLC) 2019, held in Spain.
This registration dataset consisted of the first 105 patients who had previously received chemotherapy. The median duration of response (DOR) was 20.3 months and median progression-free survival (PFS) was 18.4 months in the selpercatinib arm as of the cutoff date of Jun 17, 2019. Moreover, in the subset of patients with brain metastases, treatment with selpercatinib demonstrated a central nervous system (CNS) ORR of 91%.
Additionally, in the LIBRETTO-001 program, selpercatinib was well-tolerated with only nine of the 531 patients enrolled in the safety analysis discontinuing the therapy due to treatment-related adverse events.
The company also presented data from 34 treatment-naïve RET fusion-positive NSCLC patients treated with selpercatinib. In this analysis, selpercatinib achieved an ORR of 85%. However, duration of response (DOR) and progression-free survival (PFS) in the given patient population were not reached.
Lilly’s shares were up more than 2% in pre-market trading in response to the positive data. However, the stock has lost 1.4% so far this year, wider than the industry’s decrease of 0.5%.
Lilly plans to submit a new drug application (NDA) for selpercatinib by this year-end. If approved, selpercatinib will become the first genomically-guided precision medicine for RET fusion-positive NSCLC patients.
Notably, selpercatinib was added to Lilly’s portfolio with the February 2019 acquisition of Loxo Oncology, which broadened its scope into precision medicines. The positive data presented now validates the buyout of Loxo Oncology.
Noatbly, precision medicine is 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 receptor tyrosine RET-fusion NSCLC and plans to submit an NDA for pralsetinib pertaining to the NSCLC indication in the first quarter of 2020.
Zacks Rank & Other Stocks to Consider
Lilly currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the pharma sector include Roche Holding AG RHHBY and Merck & Co., Inc. MRK. While Roche sports a Zacks Rank #1 (Strong Buy), Merck has a Zacks Rank of 2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Roche’s earnings estimates have moved 1.2% north for 2019 and 2% for 2020 over the past 60 days. The stock has gained 11.2% year to date.
Merck’s earnings estimates have been revised 3.2% upward for 2019 and 1.3% for 2020 over the past 60 days. The stock has rallied 13.3% year to date.
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