Wedbush's Monday ASCO Roundup
The 54th annual meeting of the American Society of Clinical Oncology (ASCO) has just concluded, and there were some significant moves we saw as a result. Wedbush took a closer look at some of the companies in its coverage universe that presented on Monday and what the impact may be going forward.
Endocyte Inc. (NASDAQ: ECYT) provided an update from its clinical study of PSMA-617 that showed high prostate-specific antigen responses in metastatic castration-resistant prostate cancer patients treated, which correlated to better progression-free survival (PFS) and overall survival (OS).
Overall, the update reinforced Wedbush’s confidence of success in the Phase 3 VISION trial, which is now open for enrollment. VISION is 90% powered to show a 2.1 month OS improvement over assumed 10 month OS in control; early stoppage at 50% and 70% of events would correspond to a 4.9 month and 3.3 month OS improvement over control.
Shares of Endocyte were last seen down about 4% at $12.71, with a consensus analyst price target of $17.67 and a 52-week trading range of $1.17 to $14.86.
Karyopharm Therapeutics Inc. (NASDAQ: KPTI) reported results from the Phase 2 portion of pivotal Phase 2/3 SEAL study of selinexor in dedifferentiated liposarcoma (DDLS). The previously reported results met PFS endpoint under RECIST criteria (5.5-month versus 2.7-month with placebo). No benefit was observed under World Health Organization (WHO) criteria, which in DDLS is considered to be a poorer determinant of tumor status since it can mistakenly classify stable disease as progressive disease. Wedbush expects the Phase 3 portion will succeed as well, but the firm notes the limited economic value in the indication given rarity and short duration of use.
Karyopharm shares were trading up about 2% at $17.83, with a consensus price target of $23.36 and a 52-week range of $8.00 to $20.39.
Novocure Ltd. (NASDAQ: NVCR) announced results from its Phase 3 INNOVATE trial of TTFields in platinum-resistant ovarian cancer. There were no major surprises, except study size is larger than some investors expected, which is not concerning. INNOVATE-3 is set to start later this year and as previously announced will enroll patients with recurrent platinum-resistant ovarian cancer.
Wedbush sees INNOVATE as well powered to show a benefit with TTFields over paclitaxel alone, which in AURELIA was associated with a 3.9-month median PFS and 13.2-month median survival; results from a single arm Phase 2 show a median PFS of 8.9 months with TTFields plus paclitaxel with median OS not yet reached at last update in 2017. Although the larger trial size will drive up expenses, with $216 million in cash reported in the first quarter, the firm sees Novocure as well positioned to fund this and the three other Phase 3 trials it is running.
Novocure was trading up about 3% at $30.48 a share, with a consensus price target of $31.80 and a 52-week range of $13.35 to $32.00.
Tesaro Inc. (NASDAQ: TSRO) gave a positive update at ASCO over its QUADRA and TOPACIO studies, but this was not enough to counteract negative sentiment. Updated data from TOPACIO study showed a 28% overall response rate (ORR) and 50% disease control rate (DCR) with Zejula and pembro, with strongest activity seen in the BRCA mutation subset (60% ORR, 80% DCR and median PFS of 8.3 months).
Shares of Tesaro were last seen up about 2% at $43.25. The consensus price target is $85.31, and the 52-week range is $42.13 to $153.98.