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Bristol Myers (BMY) Announces Positive Updated NSCLC Data
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Bristol Myers Squibb (BMY - Free Report) announced updated results from the registrational TRIDENT-1 study on repotrectinib, a next-generation ROS1/TRK tyrosine kinase inhibitor (TKI) targeting ROS1- or NTRK-positive locally advanced or metastatic solid tumors.
TRIDENT-1 is a phase I/II open-label, global, multi-center, first-in-human clinical study evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of repotrectinib (TPX-0005, BMS-986472) in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC).
Results showed that repotrectinib continued to show high response rates and durable responses in patients with ROS1-positive locally advanced or metastatic NSCLC.
Median duration of response (DOR) and progression-free survival (PFS) will be disclosed for the first time in the pooled phase I/II population alongside updated results at a conference on lung cancer later in September.
The confirmed objective response rate (cORR) by Blinded Independent Central Review (BICR) was 79% in TKI-naïve patients (n=71), with a median follow-up of 24.0 months. Median DOR and PFS were 34.1 months and 35.7 months, respectively. In patients with measurable brain metastases at baseline (n=9), intracranial ORR per BICR was 89% and responses were prolonged.
In patients who had been previously treated with one TKI and no chemotherapy (n=56), with a median follow-up of 21.5 months, cORR by BICR was 38% and median DOR and PFS were 14.8 months and 9.0 months, respectively.
The updated results reflect the potential of repotrectinib as a best-in-class ROS1 inhibitor. Data from the study showed durable benefits, including in the brain, in patients with ROS1-positive NSCLC that differentiates repotrectinib from existing agents.
The study is ongoing to assess long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive advanced solid tumors.
The candidate enjoys orphan drug status in the United States. It was added to BMY’s pipeline with the acquisition of clinical-stage precision oncology company Turning Point Therapeutics in August 2022.
Bristol Myers shares have lost 13.5% in the year so far compared with the industry's decline of 13.7%.
Image Source: Zacks Investment Research
The successful development of new drugs will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis (Canada and the U.K.) face generic competition.
Last month, BMY reported weaker-than-expected second-quarter results due to continued generic competition for Revlimid. Generic competition for Eliquis is a headwind. The company also lowered its annual forecast.
Revenues in the United States declined due to lower sales of Revlimid as a result of generic erosion and an increase in the number of patients receiving free drug products for Revlimid and, to a lesser extent, Pomalyst, from the company’s patient assistance program.
While the label expansion of existing drugs and the potential approval of new drugs will add an incremental revenue stream to boost growth in the coming quarters, top-line progress is yet to be seen.
Zacks Rank and Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
The loss per share estimate for SPRO for 2023 has narrowed by 54 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 5 cents to 27 cents for 2023 in the past 30 days. Dynavax has risen 33.8% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.
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Bristol Myers (BMY) Announces Positive Updated NSCLC Data
Bristol Myers Squibb (BMY - Free Report) announced updated results from the registrational TRIDENT-1 study on repotrectinib, a next-generation ROS1/TRK tyrosine kinase inhibitor (TKI) targeting ROS1- or NTRK-positive locally advanced or metastatic solid tumors.
TRIDENT-1 is a phase I/II open-label, global, multi-center, first-in-human clinical study evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of repotrectinib (TPX-0005, BMS-986472) in patients with advanced solid tumors, including non-small cell lung cancer (NSCLC).
Results showed that repotrectinib continued to show high response rates and durable responses in patients with ROS1-positive locally advanced or metastatic NSCLC.
Median duration of response (DOR) and progression-free survival (PFS) will be disclosed for the first time in the pooled phase I/II population alongside updated results at a conference on lung cancer later in September.
The confirmed objective response rate (cORR) by Blinded Independent Central Review (BICR) was 79% in TKI-naïve patients (n=71), with a median follow-up of 24.0 months. Median DOR and PFS were 34.1 months and 35.7 months, respectively. In patients with measurable brain metastases at baseline (n=9), intracranial ORR per BICR was 89% and responses were prolonged.
In patients who had been previously treated with one TKI and no chemotherapy (n=56), with a median follow-up of 21.5 months, cORR by BICR was 38% and median DOR and PFS were 14.8 months and 9.0 months, respectively.
The updated results reflect the potential of repotrectinib as a best-in-class ROS1 inhibitor. Data from the study showed durable benefits, including in the brain, in patients with ROS1-positive NSCLC that differentiates repotrectinib from existing agents.
The study is ongoing to assess long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive advanced solid tumors.
The candidate enjoys orphan drug status in the United States. It was added to BMY’s pipeline with the acquisition of clinical-stage precision oncology company Turning Point Therapeutics in August 2022.
Bristol Myers shares have lost 13.5% in the year so far compared with the industry's decline of 13.7%.
Image Source: Zacks Investment Research
The successful development of new drugs will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis (Canada and the U.K.) face generic competition.
Last month, BMY reported weaker-than-expected second-quarter results due to continued generic competition for Revlimid. Generic competition for Eliquis is a headwind. The company also lowered its annual forecast.
Revenues in the United States declined due to lower sales of Revlimid as a result of generic erosion and an increase in the number of patients receiving free drug products for Revlimid and, to a lesser extent, Pomalyst, from the company’s patient assistance program.
While the label expansion of existing drugs and the potential approval of new drugs will add an incremental revenue stream to boost growth in the coming quarters, top-line progress is yet to be seen.
Zacks Rank and Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector are Spero Therapeutics (SPRO - Free Report) and Dynavax Technologies (DVAX - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The loss per share estimate for SPRO for 2023 has narrowed by 54 cents to 51 cents in the past 30 days. Spero’s earnings beat estimates in all of the trailing four quarters, the average surprise being 72.43%.
The loss per share estimate for DVAX has narrowed by 5 cents to 27 cents for 2023 in the past 30 days. Dynavax has risen 33.8% in the year-to-date period. DVAX’s earnings beat estimates in two of the trailing four quarters and missed in the remaining two, the average surprise being 25.78%.