Breaking News
Get Actionable Insights with InvestingPro+: Start 7 Day FREE Trial Register here
Investing Pro 0
Ad-Free Version. Upgrade your experience. Save up to 40% More details

Amgen's (AMGN) KRAS Inhibitor Gets Nod in Japan for Lung Cancer

By Zacks Investment ResearchStock MarketsJan 21, 2022 01:11AM ET
Amgen's (AMGN) KRAS Inhibitor Gets Nod in Japan for Lung Cancer
By Zacks Investment Research   |  Jan 21, 2022 01:11AM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items

Amgen Inc (NASDAQ:AMGN). AMGN announced that the Japan Ministry of Health, Labour and Welfare has approved its KRAS inhibitor, Lumakras (sotorasib). The drug is now approved in Japan for the treatment of KRAS G12C-mutated positive unresectable, advanced/recurrent non-small-cell lung cancer (“NSCLC”) in patients whose disease has progressed following systemic anti-cancer therapy.

Lumakras is the only KRAS G12C inhibitor to be approved across the world.

The approval in Japan was based on data from phase II CodeBreaK 100 study that evaluated Lumakras for NSCLC in patients with the KRAS G12C mutation. Data from the same showed that treatment with once-daily Lumakras (960 mg) led to an objective response rate of 37% in the given patient population.

Shares of Amgen have decreased 9.7% in the past year compared with the industry’s decline of 37.9%.

Zacks Investment Research
Zacks Investment Research
Image Source: Zacks Investment Research

Earlier this month, the European Commission granted conditional marketing authorization to Lumykras.

Lumykras is marketed under the trade name Lumakras in the United States.

The FDA approved Lumakras in May 2021. The approval was on an accelerated basis, with continued approval contingent on verification of data from another study to confirm the drug’s benefits. The launch of Lumakras, a first-in-class lung cancer treatment, is off to an excellent start while its label expansion studies are progressing rapidly. Lumakras generated sales worth $36 million in the third quarter of 2021.

Tumors characterized by KRAS, a common cancer mutation, are commonly associated with poor prognosis and resistance to therapy.

Amgen is exploring more than 10 sotorasib combination regimens. The company is conducting a phase II monotherapy study on sotorasib in second-line NSCLC as well as in advanced colorectal cancer (“CRC”) patients. A phase II monotherapy study in patients with KRAS G12C-mutated solid tumors, other than those suffering from NSCLC and CRC, is ongoing. A phase II study in first-line NSCLC (in patients who are either PD-L1 negative or carrying STK11 mutations) was initiated in the third quarter of 2021. A phase III study on Lumakras + Vectibix in third-line CRC is expected to begin enrollment shortly. Amgen is also conducting phase Ib combination studies with PD-1, MEK, EGFR and other targeted therapies, with some initial data expected in first half of 2022.

We note that many companies have KRAS G12C inhibitors in their pipelines being developed for various cancer indications. Mirati Therapeutics (NASDAQ:MRTX) MRTX is developing adagrasib, a KRAS G12C inhibitor, both as a monotherapy and in combination studies for treating patients with KRAS G12C-positive tumors.

In November 2021, Mirati initiated the submission of the new drug application for adagrasib to treat patients with previously treated KRAS G12C-mutated NSCLC.

Mirati is also developing adagrasib for other cancer indications.

Zacks Rank & Stocks to Consider

Amgen currently carries a Zacks Rank #3 (Hold). Top-ranked stocks in the biotech sector include Dynavax (NASDAQ:DVAX) Technologies Corporation DVAX and AnaptysBio (NASDAQ:ANAB), Inc. ANAB, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Dynavax Technologies’ earnings estimates have been revised 18% upward for 2022 over the past 60 days.The stock has skyrocketed 152% in the past year

Dynavax Technologies’ earnings have surpassed estimates in each of the trailing four quarters.

AnaptysBio’s loss per share estimates have narrowed 0.3% for 2022, over the past 60 days. The stock has rallied 21.8% in the past year.

AnaptysBio’s earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

5 Stocks Set to Double

Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2021. Previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.

Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.

Today, See These 5 Potential Home Runs >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Dynavax Technologies Corporation (DVAX): Free Stock Analysis Report

Amgen Inc. (AMGN): Free Stock Analysis Report

Mirati Therapeutics, Inc. (MRTX): Free Stock Analysis Report

AnaptysBio, Inc. (ANAB): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research
Amgen's (AMGN) KRAS Inhibitor Gets Nod in Japan for Lung Cancer

Related Articles

Amgen's (AMGN) KRAS Inhibitor Gets Nod in Japan for Lung Cancer

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with other users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind:  

  •            Enrich the conversation, don’t trash it.

  •           Stay focused and on track. Only post material that’s relevant to the topic being discussed. 

  •           Be respectful. Even negative opinions can be framed positively and diplomatically. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.

  • Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
  • NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
  • Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
  • Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at’s discretion.

Write your thoughts here
Are you sure you want to delete this chart?
Post also to:
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
Are you sure you want to delete this chart?
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Continue with Google
Sign up with Email