Authors: Renee Botello, MSc, Treatment and Trial Navigator; Daniel A. Saez, MSc, Manager of LungMATCH Navigation Program

In 2022, the treatment landscape for lung cancer continued to evolve to provide breakthrough treatment options for people living with lung cancer. This included targeting mutations that were previously unavailable for patients as well as new approvals for existing targets, giving patients more options than ever before. Additionally, new immunotherapies were approved for patients with early-stage disease, offering them additional first-line options as well as adjuvant (after first-line) treatments.  

Targeted Therapy Approvals

There were two new targeted therapy approvals last year–and one was a breakthrough approval for the HER2 mutation that was previously untargetable. Before 2022, patients with this specific mutation had no FDA approved options outside of chemotherapy and immunotherapy. The other approval created additional treatment options for patients with KRAS G12C lung cancer.,.  

New Drugs for New Targets

The drug targeting a new mutation is Enhertu (fam-trastuzumab deruxtecan-nxki). Enhertu is the first approved drug for the treatment of advanced NSCLC with an activating HER2 mutation and can only be received after a patient has tried at least one form of systemic treatment. The approval for Enhertu is based on the DESTINY-Lung02 trial which showed patients receiving Enhertu responded to treatment with durable response.  

New Drugs for Existing Targets

The other newly approved drug targeting existing mutations was Krazati (adagrasib). Krazati is the second drug to be approved for the treatment of advanced NSCLC with a KRAS G12C mutation. Prior to Krazati, the only drug available to patients was Lumakras (sotorasib). Krazati’s approval is based on the results of the KRYSTAL-1 trial showing that a large proportion of patients receiving Krazati were likely to respond and have a longer duration of response. Like Lumakras, Krazati is only available to patients who have already tried at least one form of systemic treatment.  

Immunotherapy Approvals

Libtayo in Combination with Chemotherapy for NSCLC

In 2022, one already approved drug received additional use for lung cancer patients. This drug is Libtayo (cemiplimab-rwlc) which is a PD-1 inhibitor. Previously, Libtayo was only approved for first-line treatment of patients with locally advanced or metastatic NSCLC that does not have other actionable mutations like EGFR and ALK and high PD-L1 expression. Libtayo is now available in combination with chemotherapy at any part of a patient’s treatment journey. Libtayo’s label expansion comes from the results of the Study16113 clinical trial which showed that a high percentage of patients receiving Libtayo with chemotherapy experienced better outcomes as measured by higher overall survival and time without a cancer recurrence when compared to those taking chemotherapy and a placebo. Additionally, patients receiving Libtayo and chemotherapy were more likely to respond to treatment. 

Opdivo with Chemotherapy Before Surgery for Early-Stage NSCLC

Opdivo (nivolumab) received an important addition to its FDA label in 2022, opening it as an option for more patients than before. Opdivo is now available for patients with early-stage NSCLC (IB-IIIA) in combination with platinum-based chemotherapy before surgery. Opdivo is the first immunotherapy approved for adjuvant use. Opdivo’s new addition to FDA approved use is based on the results of the CHECKMATE-816 trial which showed that patients who received Opdivo and chemotherapy before surgery went longer without recurrence following surgery and had a higher chance of the tumor responding to treatment. 

Imjudo and Imfinzi with Chemotherapy for NSCLC

Lastly, in 2022 a new combination of immunotherapy drugs was approved by the FDA. Imjudo (tremelimumab) + Imfinzi (durvalumab) received approval for the treatment of NSCLC with no changes in ALK or EGFR. The FDA based their approval on the results of the clinical trial POSEIDON which showed that a high percentage of patients receiving the combination of Imjudo and Imfizni with chemotherapy experienced better outcomes as measured by longer overall survival and time without the cancer recurring when compared to those taking chemotherapy and a placebo. Additionally, patients receiving Imjudo, Imfinzi and chemotherapy were more likely to respond to treatment. 

There are still many drugs being studied in clinical trials that could be options for you or a loved one. If you would like to discuss treatment or clinical trial options, please call our free HelpLine at 1-800-298-2436 and ask to speak to a LungMATCH treatment and trials navigator.