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Amgen's (AMGN) KRAS Inhibitor Gets Breakthrough Tag for NSCLC
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Amgen Inc. (AMGN - Free Report) announced that the FDA has granted a Breakthrough Therapy designation to its investigational KRAS inhibitor sotorasib for the treatment of locally advanced/metastatic non-small-cell lung cancer (“NSCLC”) in patients with KRAS G12C mutation.
The prestigious tag was based on positive data from the phase II CodeBreaK 100 study, which evaluated sotorasib in patients with advanced NSCLC whose disease progressed despite prior treatment with chemotherapy and/or immunotherapy. Data from the study showed that treatment with sotorasib led to durable anticancer activity with a positive benefit-risk profile in the given patient population.
Shares of Amgen have lost 5% so far this year against the industry’s increase of 5.9%.
The FDA’s Breakthrough Therapy tag is granted to expedite development and review of drugs that target serious or life-threatening conditions. The new medicine needed to have shown encouraging early clinical results that demonstrate a substantial improvement of a clinically significant endpoint over other approved medicines.
Notably, tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy.
Per the company, KRAS G12C mutations are present in approximately 13% of NSCLC adenocarcinomas with around 25,000 new patients diagnosed each year in the United States. There is a high unmet medical need for the given indication as NSCLC patients with KRAS G12C mutation who have failed first-line treatment have limited treatment options available. If sotorasib is successfully developed and upon potential approval, it can serve a market with significantly unmet need.
Moreover, sotorasib has also been accepted into the FDA's Real-Time Oncology Review Pilot Program, which ensures a more efficient review process and provides safe and effective treatments to patients as early as possible.
The company plans to submit a new drug application for sotorasib to treat NSCLC patients with KRAS G12C mutation by 2020-end.
Sotorasib is also being evaluated in a phase II monotherapy study in advanced colorectal cancer patients. Amgen is also conducting phase Ib combination studies on sotorasib with PD-1, MEK and other targeted therapies.
We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Apart from Amgen, Eli Lilly (LLY - Free Report) and J&J (JNJ - Free Report) have KRAS G12C inhibitor candidates in their pipelines. Small biotech, Mirati Therapeutics is also developing its pipeline candidate, adagrasib, a KRAS inhibitor to address patients with KRAS G12C-positive tumors.
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 2021.
Image: Shutterstock
Amgen's (AMGN) KRAS Inhibitor Gets Breakthrough Tag for NSCLC
Amgen Inc. (AMGN - Free Report) announced that the FDA has granted a Breakthrough Therapy designation to its investigational KRAS inhibitor sotorasib for the treatment of locally advanced/metastatic non-small-cell lung cancer (“NSCLC”) in patients with KRAS G12C mutation.
The prestigious tag was based on positive data from the phase II CodeBreaK 100 study, which evaluated sotorasib in patients with advanced NSCLC whose disease progressed despite prior treatment with chemotherapy and/or immunotherapy. Data from the study showed that treatment with sotorasib led to durable anticancer activity with a positive benefit-risk profile in the given patient population.
Shares of Amgen have lost 5% so far this year against the industry’s increase of 5.9%.
The FDA’s Breakthrough Therapy tag is granted to expedite development and review of drugs that target serious or life-threatening conditions. The new medicine needed to have shown encouraging early clinical results that demonstrate a substantial improvement of a clinically significant endpoint over other approved medicines.
Notably, tumors characterized by KRAS mutations are commonly associated with poor prognosis and resistance to therapy.
Per the company, KRAS G12C mutations are present in approximately 13% of NSCLC adenocarcinomas with around 25,000 new patients diagnosed each year in the United States. There is a high unmet medical need for the given indication as NSCLC patients with KRAS G12C mutation who have failed first-line treatment have limited treatment options available. If sotorasib is successfully developed and upon potential approval, it can serve a market with significantly unmet need.
Moreover, sotorasib has also been accepted into the FDA's Real-Time Oncology Review Pilot Program, which ensures a more efficient review process and provides safe and effective treatments to patients as early as possible.
The company plans to submit a new drug application for sotorasib to treat NSCLC patients with KRAS G12C mutation by 2020-end.
Sotorasib is also being evaluated in a phase II monotherapy study in advanced colorectal cancer patients. Amgen is also conducting phase Ib combination studies on sotorasib with PD-1, MEK and other targeted therapies.
We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Apart from Amgen, Eli Lilly (LLY - Free Report) and J&J (JNJ - Free Report) have KRAS G12C inhibitor candidates in their pipelines. Small biotech, Mirati Therapeutics is also developing its pipeline candidate, adagrasib, a KRAS inhibitor to address patients with KRAS G12C-positive tumors.
Zacks Rank
Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) 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 2021.
Click here for the 6 trades >>