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Bristol-Myers Reports Disappointing Data From SCLC Study
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Bristol-Myers Squibb Company (BMY - Free Report) reported disappointing top-line results from the phase III study, Checkmate-331, which evaluated blockbuster immuno-oncology drug, Opdivo compared to the current standard of care, topotecan or amrubicin, in patients with small cell lung cancer (SCLC) who relapsed, following platinum-based chemotherapy.
The study is an open-label, randomized phase III study, evaluating Opdivo monotherapy compared to chemotherapy in patients with relapsed SCLC, following platinum-based chemotherapy.
The patients enrolled in the trial were randomized to two treatment arms — an experimental arm assessing Opdivo and an active comparator arm evaluating topotecan. The primary objective was overall survival (OS). The secondary endpoints included progression-free survival and objective response rate.
The study did not meet its primary endpoint even though the safety profile was consistent.
We note that the FDA approved Opdivo for the treatment of patients with metastatic SCLC, whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy, in August 2018. This indication is approved under accelerated approval based on overall response rate and duration of response. However, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.
Nevertheless, the company is evaluating the combination of Opdivo plus Yervoy and Opdivo monotherapy compared to placebo in the frontline setting as a maintenance therapy for patients with SCLC, who do not progress on first-line chemotherapy.
Opdivo is currently approved in several countries, including the United States, the EU and Japan for several cancer indications — classical Hodgkin lymphoma in both the United States and the EU, and recurrent or metastatic squamous cell carcinoma of the head and neck, among others. The drug has been performing impressively due to demand resulting from the rapid commercial acceptance for several indications, including melanoma, renal cell carcinoma and second-line non-small-cell lung cancer (“NSCLC”). Applications for Opdivo plus Yervoy in first line NSCLC were accepted both in the United States and Europe, and are under review. Opdivo was also approved for the adjuvant treatment of adult patients with melanoma.
Last week, Bristol-Myers announced that it has entered a clinical trial collaboration with Compugen (CGEN - Free Report) to evaluate the safety and tolerability of the latter’s COM701, an investigational antibody, in combination with Bristol-Myers' immune checkpoint inhibitor, Opdivo, in patients with advanced solid tumors.
However, year to date, shares of Bristol-Myers have declined 3.7% against the industry’s growth of 6.3%.
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Bristol-Myers Reports Disappointing Data From SCLC Study
Bristol-Myers Squibb Company (BMY - Free Report) reported disappointing top-line results from the phase III study, Checkmate-331, which evaluated blockbuster immuno-oncology drug, Opdivo compared to the current standard of care, topotecan or amrubicin, in patients with small cell lung cancer (SCLC) who relapsed, following platinum-based chemotherapy.
The study is an open-label, randomized phase III study, evaluating Opdivo monotherapy compared to chemotherapy in patients with relapsed SCLC, following platinum-based chemotherapy.
The patients enrolled in the trial were randomized to two treatment arms — an experimental arm assessing Opdivo and an active comparator arm evaluating topotecan. The primary objective was overall survival (OS). The secondary endpoints included progression-free survival and objective response rate.
The study did not meet its primary endpoint even though the safety profile was consistent.
We note that the FDA approved Opdivo for the treatment of patients with metastatic SCLC, whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy, in August 2018. This indication is approved under accelerated approval based on overall response rate and duration of response. However, continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.
Nevertheless, the company is evaluating the combination of Opdivo plus Yervoy and Opdivo monotherapy compared to placebo in the frontline setting as a maintenance therapy for patients with SCLC, who do not progress on first-line chemotherapy.
Opdivo is currently approved in several countries, including the United States, the EU and Japan for several cancer indications — classical Hodgkin lymphoma in both the United States and the EU, and recurrent or metastatic squamous cell carcinoma of the head and neck, among others. The drug has been performing impressively due to demand resulting from the rapid commercial acceptance for several indications, including melanoma, renal cell carcinoma and second-line non-small-cell lung cancer (“NSCLC”). Applications for Opdivo plus Yervoy in first line NSCLC were accepted both in the United States and Europe, and are under review. Opdivo was also approved for the adjuvant treatment of adult patients with melanoma.
Last week, Bristol-Myers announced that it has entered a clinical trial collaboration with Compugen (CGEN - Free Report) to evaluate the safety and tolerability of the latter’s COM701, an investigational antibody, in combination with Bristol-Myers' immune checkpoint inhibitor, Opdivo, in patients with advanced solid tumors.
However, year to date, shares of Bristol-Myers have declined 3.7% against the industry’s growth of 6.3%.
Opdivo faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.
Zacks Rank
Bristol-Myers currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
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