Celgene Corporation (NASDAQ:CELG) announced interim results from the ABOUND clinical trial program evaluating the use of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in patients with advanced non-small cell lung cancer (NSCLC). Interim data being presented from the ABOUND trials during the IASLC 17th World Conference on Lung Cancer (WCLC) reinforces the benefit of ABRAXANE/carboplatin doublet therapy in first-line NSCLC.
Interim ABOUND.70+ data in 128 elderly patients (≥ 70 years old) receiving first-line treatment with ABRAXANE/carboplatin for advanced NSCLC found that 91 (73%) patients experienced grade ≥2 peripheral neuropathy (PN) or grade ≥3 myelosuppression [primary endpoint]. At the time of the analyses, the median overall survival was 14.6 months and the median progression-free survival was 6.2 months, pooled across the two treatment arms [secondary endpoints]. Patients were randomized to receive first-line treatment with ABRAXANE/carboplatin either continuous weekly or weekly every three weeks with a one-week break. Overall, 80 percent of patients discontinued treatment and the majority did so due to adverse events (24 percent) or disease progression (34 percent). Grade ≥2 PN was reported in 34% of patients, and grade ≥3 neutropenia, anemia, and thrombocytopenia was observed in 52%, 21% and 21% of patients, respectively.
The interim ABOUND.sqm data in 284 patients receiving first-line induction treatment with ABRAXANE/carboplatin for stage IIIB/IV squamous NSCLC showed that the safety profile was consistent with that previously reported for the squamous subset in the pivotal Phase III trial.ii,iii During the induction phase, all patients received four 21-day cycles of standard ABRAXANE/carboplatin therapy.ii Overall, 119 patients (42 percent) discontinued treatment during the induction phase. The majority of patients discontinued treatment due to disease progression (34 percent) or adverse events (24 percent). The most common grade 3/4 treatment emergent adverse events (TEAEs) were hematologic and included anemia (26 percent), neutropenia (43 percent) and thrombocytopenia (15 percent).
Both ABOUND trials also evaluated quality of life utilizing the Lung Cancer Symptom 3-item index Scale (LCSS), Symptom Burden Index, Lung Cancer Symptom and Pulmonary Symptom Scores and the EuroQol five dimensions, five level questionnaire (EQ-5D-5L). These interim analyses suggest that quality of life was generally maintained or improved in both patient populations.iv,v
“These early data from the ABOUND clinical trial program are very encouraging, as they are consistent with the findings related to these hard to treat non-small cell lung cancer patient subgroups seen in the pivotal ABRAXANE Phase III trial,” said Michael Pehl, President, Hematology and Oncology for Celgene. “These data, coupled with the ongoing studies of ABRAXANE in combination with novel agents and immunotherapies, provide us with a deeper understanding of how to treat challenging patient populations and will help us continue to develop future treatment options.”
With the rapidly evolving lung cancer treatment landscape, Celgene remains committed to continuing to explore new combinations that will benefit those living with lung cancer, including patients who may not benefit from immunotherapy and targeted therapy. ABRAXANE is being actively evaluated as a foundation therapy in these patients.
Interim results of the phase I study of the immunotherapy agent nivolumab in combination with ABRAXANE/carboplatin in 22 patients with Stage IIIB/IV NSCLC will also be presented at WCLC. Patients received four cycles of standard ABRAXANE/carboplatin therapy in combination with nivolumab, followed by nivolumab monotherapy starting at cycle 5. The primary endpoints were number of patients with dose limiting toxicity and percentage of patients with grade 3/4 TEAEs or treatment discontinuation due to a TEAE. The interim data suggests that combining ABRAXANE/carboplatin with nivolumab may have promising anti-tumor activity in patients with advanced NSCLC with no unexpected adverse events (AEs).
The most common grade 3/4 AEs observed during the study included neutropenia (45 percent), anemia (35 percent), hypokalemia (15 percent), and vomiting (15 percent). The study has been expanded and patients are currently enrolling in part 2. Additional data on the safety and efficacy of this combination in multiple tumor types will be presented at a future medical meeting.
Additional ABRAXANE Data Presented at WCLC
There will also be an oral presentation at WCLC focused on new findings from the phase III registration study for ABRAXANE (Abstract 4460), which reports on the impact of depth of response on survival in patients with advanced NSCLC treated with first-line chemotherapy. Real-world analyses of US veterans with NSCLC are also being presented at WCLC, evaluating prevalence of squamous NSCLC in veterans vs. the general population (Abstract 4737) and the prevalence of autoimmune disease in veterans with NSCLC (Abstract 4745).
Additional investigator initiated studies presented at WCLC also evaluated ABRAXANE as first-line (Posters P2.03a-028 and P2.06-018), second-line (Posters P2.03a-040, P2.03a-054 and P2.03a-056) or third-line (Poster P2.06-015) treatment for advanced NSCLC patients, as well as in the adjuvant (Poster P2.03a-070) and neoadjuvant (Poster P2.04-034) settings and in chemo-naïve patients with an EGFR mutation (Poster P3.02b-061). (Original Source)
Shares of Celgene Corporation shares are currently trading at $117.56, up $1.00 or +0.88%. CELG has a 1-year high of $127 and a 1-year low of $93.05. The stock’s 50-day moving average is $99.91 and its 200-day moving average is $105.84.
On the ratings front, Celgene Corporation has been the subject of a number of recent research reports. In a report released yesterday, Cantor Fitzgerald analyst Mara Goldstein reiterated a Buy rating on CELG, with a price target of $159, which implies an upside of 36% from current levels. Separately, on the same day, BMO’s Ian Somaiya reiterated a Buy rating on the stock and has a price target of $142.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mara Goldstein and Ian Somaiya have a yearly average return of 2.6% and 11.2% respectively. Goldstein has a success rate of 44% and is ranked #1119 out of 4256 analysts, while Somaiya has a success rate of 52% and is ranked #314.
Overall, 3 research analysts have assigned a Hold rating and 14 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $140.67 which is 20.7% above where the stock closed yesterday.
Celgene Corp. is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Its targeting areas include intracellular signaling pathways, protein homeostasis and epigenetics in cancer and immune cells, immunomodulation in cancer and autoimmune diseases and therapeutic application of cell therapies.