FDA Approves Atezolizumab as Adjuvant Immunotherapy for Lung Cancer


The Food and Drug Administration (FDA) has granted its stamp of approval to use adjuvant immunotherapy atezolizumab for lung cancer, an immunotherapy medication. This significant development allows for the utilization of atezolizumab as an adjunctive therapy following surgical and chemotherapy interventions in specific cases of non-small cell lung cancer (NSCLC).

This landmark decision represents a groundbreaking milestone in the realm of lung cancer treatment, as it signifies the inaugural instance of immunotherapy being endorsed as an adjuvant treatment for individuals grappling with this form of cancer.

Considerations Upon Using Atezolizumab as Adjuvant Chemotherapy for Lung Cancer

On October 15, the green light was given for patients with a specific stage of lung cancer. This type of cancer is called NSCLC, and it’s at a stage where it hasn’t spread very far from the tumor. To qualify for this treatment, patients need to have a certain protein called PD-L1 on at least 1% of their cancer cells. Doctors will use a special test approved by the FDA to check for this protein before giving atezolizumab adjuvant for NSCLC patients. The FDA also said it’s okay to use a test called Ventana PD-L1 (AP263) to figure out if a patient can get this new treatment called atezolizumab.

The FDA made this decision based on a big study called IMpower010. In this study, over 1,000 patients with NSCLC had their tumors removed with surgery. First, they all got some extra treatment after surgery to prevent the cancer from coming back. Then, by chance, some of them got atezolizumab, while others got the best care and support possible.

Atezolizumab Tecentriq Adjuvant Therapy for NSCLC: Notable Advancements Toward Lung Cancer

Patients get extra treatments to lower the chances of cancer returning after their main treatment, like surgery. These extra treatments can be things like strong medicines (chemotherapy), radiation, special hormones, or targeted therapy. Even though lots of folks with early-stage lung cancer (NSCLC) get chemotherapy after surgery, the cancer often comes back later.

Trials like IMpower010 are responsible for checking if certain medicines can help keep NSCLC from coming back after surgery. The ALCHEMIST trial, which the National Cancer Institute supports, is looking at a medicine called nivolumab (Opdivo) for this. Another study named PEARLS is trying out pembrolizumab (Keytruda).

IMpower010 was the first of these studies to tell us what they found. A doctor named Justin Gainor from Massachusetts General Hospital said this is a big deal. He wrote about it in a magazine called The Lancet before the FDA gave its OK.

Some medicines, like atezolizumab, are already allowed to be used at the beginning when NSCLC has spread.

What are the Results of the IMpower010 Trial?

In the IMpower010 study, where 495 patients took atezolizumab as an adjuvant immunotherapy for lung cancer, some side effects happened. These included rashes (17%), coughing (16%), hypothyroidism (14%), pyrexia (14%), fatigue/asthenia (14%), feeling weak (14%), and having peripheral neuropathy (14%). Some of these side effects were not very bad (grade 1 or 2), but a few were more serious (grade 3 or 4), like the rash (1.2%), pyrexia (0.8%), and strong muscle or joint pain or musculoskeletal pain (0.8%). There were also some changes in blood tests, like having too much potassium (3.5%), or having higher levels of two liver enzymes, ALT (3.3%) and AST (2.5%).

Around 18% of patients had serious side effects. The most common serious side effects were pneumonia (1.8%), lung problems called pneumonitis (1.6%), and having a fever (1.2%). For some patients, the side effects were so bad that they had to stop the treatment (18% of patients). The main reasons for stopping were lung problems (2.2%), a low thyroid (1.6%), high AST (1.4%), joint pain (1.0%), and high ALT (1.0%). Sadly, some patients (1.8%) passed away because of side effects. These included problems with many organs, air leaking into the chest (pneumothorax), lung problems, heart rhythm issues (arrhythmia), heart failure, heart muscle inflammation (myocarditis), stroke, unknown causes, and a type of blood cancer called acute myeloid leukemia.

Atezolizumab comes with warnings. It can cause problems with the immune system (like lung, gut, liver, hormone gland, skin, kidney, and transplant problems). Some people might have reactions when they get the medicine through an IV. There are also concerns for people who had a transplant with someone else’s blood cells. Lastly, it might be harmful to babies if their mothers take it while breastfeeding.

A Groundbreaking Treatment for NSCLC

Atezolizumab added after surgery could be a good treatment choice for certain lung cancer patients. However, there’s a catch. The big study called IMpower010 couldn’t tell us yet if atezolizumab makes patients live longer compared to those who don’t get it.

Still, other research on lung cancer patients has hinted that keeping the disease under control for longer might be really helpful for them. Knowing this, along with what we’ve learned from IMpower010, makes it seem like adjuvant atezolizumab could be useful for the right lung cancer patients.

Adjuvant Immunotherapy Using Atezolizumab for Lung Cancer

The FDA’s approval of adjuvant atezolizumab as a groundbreaking treatment for certain NSCLC patients marks a significant stride in the fight against lung cancer. While the IMpower010 study couldn’t definitively show if atezolizumab extends life, the promise of prolonged disease control offers hope. As we delve further into the realm of immunotherapy and its potential to enhance patient outcomes, it is crucial that healthcare professionals and individuals affected by NSCLC stay informed about these advancements.

Together, we can ensure that the right patients receive the right treatments, and by advocating for ongoing research and access to innovative therapies, we move one step closer to a brighter future in the battle against lung cancer. Stand up for progress, spread awareness, and support initiatives that empower patients and healthcare providers in making informed treatment decisions.


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