Analyst Sees Exelixis At Inflection Point Despite Mixed Trial Results
Analyst Sees Exelixis At Inflection Point Despite Mixed Trial Results
As previously reported, the CONTACT-02 study met one of its two primary endpoints, demonstrating a statistically significant benefit in progression-free survival (PFS) (hazard ratio: 0.65; p=0.0007) in the predefined PFS intent-to-treat population (i.e., the first 400 randomized patients).In its second-quarter earnings release, Exelixis, Inc. (NASDAQ:EXEL) announced that the final overall survival (OS) analysis for the phase 3 CONTACT-02 trial has been completed.
伊克力西斯公司（纳斯达克股票代码：EXEL）在其第二季度财报发布中宣布，第三期CONTACt-02试验的最终总体生存（OS）分析已经完成。
This study evaluates cabozantinib in combination with atezolizumab compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable soft-tissue disease who have progressed after treatment with one prior NHT.
该研究比较了卡博替尼联合阿特伊珠单抗与第二个新的激素治疗（NHT），用于转移性去势抵抗性前列腺癌（mCRPC）和可测量软组织疾病的患者，这些患者在接受一种先前的NHT治疗后已经进展。
Also Read: Bristol Myers, Exelixis Reveal 4-Year Follow-Up Results From Cancer Treatment Study.
同时阅读：Bristol Myers和Exelixis公布癌症治疗研究的4年随访结果。
As previously reported, the CONTACT-02 study met one of its two primary endpoints, demonstrating a statistically significant benefit in progression-free survival (PFS) (hazard ratio: 0.65; p=0.0007) in the predefined PFS intent-to-treat population (i.e., the first 400 randomized patients).
正如之前报道的那样，CONTACt-02研究实现了两个主要终点的其中一个，在预定义的进展无病生存（PFS）意向治疗总体人群（即，前400名随机患者）中显示出统计学有意义的益处（风险比：0.65；p = 0.0007）。
While the final OS continued to favor the combination of cabozantinib and atezolizumab, it did not achieve statistical significance.
虽然最终的OS仍然有利于卡博替尼联合阿特伊珠单抗，但并没有达到统计学意义。
The safety profile of the combination regimen was reflective of the known safety profiles for each single agent and was consistent with the known tolerability profile of approved immune checkpoint inhibitor-tyrosine kinase inhibitor combinations in advanced solid tumors.
该联合方案的安全剖面反映了每个单一制剂的已知安全剖面，并且与晚期实体瘤批准的免疫检查点抑制剂-酪氨酸激酶抑制剂联合剂型的已知耐受性剖面一致。
Despite the trial update, the company intends to submit a supplemental marketing application to the FDA in 2024.
尽管有试验更新，但该公司仍打算在2024年向美国FDA提交补充营销申请。
Exelixis reported second-quarter adjusted EPS of $0.84, higher than $0.31 a year ago, beating the consensus of $0.30.
Exelixis报告的第二季度调整后每股收益为0.84美元，高于去年同期的0.31美元，超过0.30美元的共识。
The sales increased to $637.2 million, beating the consensus of $465 million, up from $469.8 million a year ago, primarily due to increased sales volume and average net selling price.
销售额增长至6,372百万美元，高于去年同期的4,698百万美元，主要是由于销售量和平均净售价的增加。
Guidance: Exelixis sees 2024 revenues of $1.975 billion—$2.075 billion versus a consensus of $1.88 billion and prior guidance of $1.825 billion—$1.925 billion.
指导：Exelixis预计2024年的营业收入为19.75亿美元至20.75亿美元，而共识为18.8亿美元，先前的指导为18.25亿美元至19.25亿美元。
William Blair writes that Exelixis has entered 2024 at an inflection point. The growth of its flagship Cabometyx franchise is stabilizing, while pipeline programs, especially zanzalintinib, are increasingly responsible for offsetting Cabometyx's market exclusivity expiry in 2031.
William Blair表示，Exelixis已经在2024年进入了一个拐点。旗舰Cabometyx系列药物的增长正在稳定，而管线计划（特别是zanzalintinib）越来越多地负责抵消Cabometyx在2031年市场独占的到期。
In the midterm, NETs and mCRPC could emerge as material growth opportunities for the franchise.
在中期内，NET和mCRPC可能成为系列药物的实质性增长机会。
"Ultimately, given the cash flow generation and EPS positivity, we believe Exelixis provides investors with a highly defensive investment profile," the analyst adds.
该分析师补充说：“最终，考虑到现金流的产生和EPS的积极性，我们认为Exelixis为投资者提供了高度防御性的投资配置。”
The analyst reiterates the Outperform rating on Exelixis shares.
该分析师重申对Exelixis股票的表现评级。
Price Action: EXEL stock is up 13% at $26.49 at last check Wednesday.
价格走势：EXEL股票上涨13％，最后报价26.49美元，星期三。
Photo via Shutterstock
图片来自shutterstock。
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