We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol Myers (BMY) Reports Positive Colorectal Cancer Study Data
Read MoreHide Full Article
Bristol Myers Squibb (BMY - Free Report) announced data from the cohorts of the KRYSTAL-1 study, evaluating the lung cancer drug Krazati (adagrasib) in combination with Erbitux (cetuximab), for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).
KRYSTAL-1 is an open-label, multicenter, multiple expansion cohort phase I/II study to determine the safety and efficacy of Krazati in patients with advanced solid tumors that harbor a KRASG12C mutation.
The primary endpoint for the phase II cohort of the KRYSTAL-1 study was the objective response rate (ORR). Secondary endpoints included the duration of response, progression-free survival (PFS), and overall survival and safety.
The combination of Krazati and cetuximab demonstrated clinically meaningful activity as a targeted treatment option for CRC patients. The combination demonstrated an ORR of 34% with a median follow-up of 11.9 months in 94 patients. The median progression-free survival and the median overall survival was 6.9 months and 15.9 months, respectively, in pre-treated patients with KRASG12C-mutated locally advanced or metastatic CRC.
The median duration of response was 5.8 months. Disease control was observed in 85% of patients. The safety profile of the combination was manageable and consistent with the previous reports and the known safety profile of each drug.
Per BMY, KRASG12C mutations act as oncogenic drivers and are found in approximately 3-4% of colorectal cancers. Also, treatment with cetuximab as a single agent did not offer a clinical benefit in patients with KRAS-mutated colorectal cancer, as observed in previous studies.
We remind investors that the FDA had accepted a supplemental new drug application for Krazati, in combination with cetuximab, as a targeted treatment option for these patients. The regulatory body has granted priority review to the application and set a target action date of Jun 21, 2024.
The FDA has already granted breakthrough therapy designation to Krazati, in combination with cetuximab, in patients with KRASG12C-mutated advanced CRC whose cancer has progressed following prior treatment with chemotherapy and anti-VEGF therapy.
The drug was added to BMY’s portfolio with the January acquisition of Mirati Therapeutics.
Krazati obtained accelerated approval for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. The accelerated approval was based on ORR and duration of response.
The drug is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC and colorectal cancer.
Krazati has also been approved in the European Union as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy.
Last month, BMY announced that the late-stage KRYSTAL-12 study, evaluating Krazati as a monotherapy in patients with pretreated locally advanced or metastatic NSCLC harboring a KRASG12C mutation, met the primary endpoint of PFS and the key secondary endpoint of ORR as assessed by Blinded Independent Central Review at final analysis for these endpoints.
The study is underway to assess the additional key secondary endpoint of overall survival. Results of the confirmatory trial showed that Krazati demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
Shares of Bristol Myers have plunged 27.3% in the past year compared with the industry’s decline of 13.2%.
Image Source: Zacks Investment Research
BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis. Approval of new drugs and label expansion of the existing ones are important for BMY and the going has been good in that regard.
BMY has recently obtained regulatory approvals for the label expansion of its two CAR T cell therapies — Abecma and Breyanzi. The company also received the European Commission's approval for the label expansion of Reblozyl (luspatercept).
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have improved from 22 to 30 cents. In the past year, shares of ADMA have surged 88.5%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
In the past 60 days, estimates for GLPG’s loss have narrowed from $1.68 per share to 40 cents.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.06 to $4.43. In the past year, shares of ANIP have surged 75.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Bristol Myers (BMY) Reports Positive Colorectal Cancer Study Data
Bristol Myers Squibb (BMY - Free Report) announced data from the cohorts of the KRYSTAL-1 study, evaluating the lung cancer drug Krazati (adagrasib) in combination with Erbitux (cetuximab), for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC).
KRYSTAL-1 is an open-label, multicenter, multiple expansion cohort phase I/II study to determine the safety and efficacy of Krazati in patients with advanced solid tumors that harbor a KRASG12C mutation.
The primary endpoint for the phase II cohort of the KRYSTAL-1 study was the objective response rate (ORR). Secondary endpoints included the duration of response, progression-free survival (PFS), and overall survival and safety.
The combination of Krazati and cetuximab demonstrated clinically meaningful activity as a targeted treatment option for CRC patients. The combination demonstrated an ORR of 34% with a median follow-up of 11.9 months in 94 patients. The median progression-free survival and the median overall survival was 6.9 months and 15.9 months, respectively, in pre-treated patients with KRASG12C-mutated locally advanced or metastatic CRC.
The median duration of response was 5.8 months. Disease control was observed in 85% of patients. The safety profile of the combination was manageable and consistent with the previous reports and the known safety profile of each drug.
Per BMY, KRASG12C mutations act as oncogenic drivers and are found in approximately 3-4% of colorectal cancers. Also, treatment with cetuximab as a single agent did not offer a clinical benefit in patients with KRAS-mutated colorectal cancer, as observed in previous studies.
We remind investors that the FDA had accepted a supplemental new drug application for Krazati, in combination with cetuximab, as a targeted treatment option for these patients. The regulatory body has granted priority review to the application and set a target action date of Jun 21, 2024.
The FDA has already granted breakthrough therapy designation to Krazati, in combination with cetuximab, in patients with KRASG12C-mutated advanced CRC whose cancer has progressed following prior treatment with chemotherapy and anti-VEGF therapy.
The drug was added to BMY’s portfolio with the January acquisition of Mirati Therapeutics.
Krazati obtained accelerated approval for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. The accelerated approval was based on ORR and duration of response.
The drug is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC and colorectal cancer.
Krazati has also been approved in the European Union as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy.
Last month, BMY announced that the late-stage KRYSTAL-12 study, evaluating Krazati as a monotherapy in patients with pretreated locally advanced or metastatic NSCLC harboring a KRASG12C mutation, met the primary endpoint of PFS and the key secondary endpoint of ORR as assessed by Blinded Independent Central Review at final analysis for these endpoints.
The study is underway to assess the additional key secondary endpoint of overall survival. Results of the confirmatory trial showed that Krazati demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
Shares of Bristol Myers have plunged 27.3% in the past year compared with the industry’s decline of 13.2%.
Image Source: Zacks Investment Research
BMY is looking to expand its new product portfolio amid generic challenges for Revlimid and Eliquis. Approval of new drugs and label expansion of the existing ones are important for BMY and the going has been good in that regard.
BMY has recently obtained regulatory approvals for the label expansion of its two CAR T cell therapies — Abecma and Breyanzi. The company also received the European Commission's approval for the label expansion of Reblozyl (luspatercept).
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the biotech sector are ADMA Biologics, Inc. (ADMA - Free Report) , Galapagos (GLPG - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have improved from 22 to 30 cents. In the past year, shares of ADMA have surged 88.5%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met once, delivering an average surprise of 85.00%.
In the past 60 days, estimates for GLPG’s loss have narrowed from $1.68 per share to 40 cents.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have improved from $4.06 to $4.43. In the past year, shares of ANIP have surged 75.5%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.