Two new drug approvals (for patients with EGFR Exon 20 insertion and patients with KRAS G12C mutation)

[Miranda_GO2]

Hi everyone,

I know Denzie posted about at least one of the new drug approvals fbut I figured it can't hurt to post about the new approvals again so people are aware of them.

With both approvals, I wanted to share why it's important to know what your biomarker test results. Sometimes healthcare professionals will tell patients that they didn't have any "actionable mutations" this means that there isn't a drug approved for that mutation at the time of testing, but knowing what your specific results are can help you to understand if you may qualify for clinical trials for other mutations or if you might qualify for a drug once it gets approval. Be sure to ask your doctor for a copy of your biomarker testing results and feel free to ask them to explain it to you. If you need additional support in understanding what the report is saying, feel free to contact GO2 Foundation's Lung MATCH team so we can help.

Now on with the announce about the approvals:

**The first one that came out was for Rybrevant, it is the first targeted treatment for patients with NSCLC with EGFR Exon 20 Insertion Mutations

On May 21st, 2021, the Food and Drug Administration (FDA) approved Rybrevant (amivantamab-vmjw) for treatment of advanced non-small cell lung cancer (NSCLC) with a change in EGFR called exon 20 insertion. The FDA based their approval on the results of the clinical trial CHRYSALIS which showed that patients receiving Rybrevant responded to the drug for a year.

In addition to approving Rybrevant, the FDA also granted approval for Guardant360 CDx as a companion diagnostic. Rybrevant marks the first drug to receive approval from the FDA for patients with the exon 20 insertion change delivering hope and a new option to a large population of patients. Here is the full FDA Press release": fda.gov/news-events/press-a...

***The second was the first targeted therapy approval for non-small cell lung cancer with KRAS Mutation (specifically KRAS G12C)

On May 28, 2021 the United States Food and Drug Administration (FDA) approved Lumakras (sotorasib) for the first line treatment of advanced non-small cell lung cancer (NSCLC) with tumors having the G12C change in KRAS. The FDA based their approval on the results of the clinical trial CODEBREAK 100 which showed that patients receiving Lumakras (sotorasib) had a higher chance of responding well or not having cancer progression while on treatment.

Lumakras (sotorasib) being available marks the first drug approved by the FDA to target KRAS. This landmark approval finally gives patients with the most common mutation in non-small cell lung cancer hope for a targeted therapy that did not exist before. Here is the full FDA press release for that approval: fda.gov/news-events/press-a...

Feel free to message me if you have any questions about these new approvals for biomarker testing.

[Todd04]

Hi Miranda,I am stage 1a. I had a lobectomy and no further treatment at this time. Would it still be wise to have bio marker testing done on my tumor?

[Miranda_GO2 Partner in reply to Todd04]

Hello Todd04,

When did you have the surgery? Right now the standard of care according to the NCCN guidelines doesn't indicate a need for additional adjuvant treatment for stage IA if margins are clear (meaning all the cancer is removed). Here is the link for the patient version of those NCCN guidelines referenced on page 40 and through: nccn.org/patients/guideline...

As an advocacy organization we suggest everyone with NSCLC get comprehensive testing initially, but since you are post treatment it's hard to justify since it won't change your treatment path being that you had IA. On December 18th, 2020, the Food and Drug Administration (FDA) approved Tagrisso (osimertinib) for the adjuvant treatment of stage IB-IIIA non-small cell lung cancer (NSCLC) that has been surgically removed, when the cancer has a change in EGFR, but stage IA wasn't indicated for this.

I hope that answered your questions but let me know if it didn't or if you have more questions.

[Todd04 in reply to Miranda_GO2]

Thank you Miranda! I appreciate you replying and sending me this information.