Immuno-anticancer drugs have brought us closer

to the goal of curing lung cancer

The era of adjuvant immunotherapy before and after lung cancer surgery has opened

Keytruda and Opdivo significantly improved the pathological complete response

Professor Lee Se-hoon, "I was surprised even on the spot. The number of options increased significantly"

Product photos of Opdivo (left) and Keytruda

Immuno-anticancer agents are active in early lung cancer.

 

Following 'Opdivo (Nivolumab),' which obtained the indication for adjuvant therapy before surgery for the first time, 'Keytruda (Pembrolizumab)' is also seeking to expand its scope as adjuvant therapy before and after surgery.

 

The data shown by immuno-anticancer drugs in early lung cancer were surprising.

 

When chemotherapy and CCRT were used, 'pCR', which was seen in 1 or 2 out of 100 patients, increased more than 10 times.

 

In the case of Opdivo, a pCR of 24% was recorded in CheckMate-816 phase 3, significantly improving the 2.2% of the chemotherapy alone group.

 

At 3 years, EFS was 57%, exceeding the control group's 43%.

 

Keytruda also had an event-free survival rate of 62.4% at 2 years, which was significantly higher than that of the control group, 40.6%.

 

The mPR and pCR ratios were 30.2% and 18.1%, respectively, demonstrating a greater improvement than the control group of 11% and 4%.

 

Lee Se-hoon, a professor of hemato-oncology at Samsung Seoul Hospital, said in a recent interview with Daily Pharm, "If Opdivo caused a 'frenzy' as an adjuvant therapy before surgery, Keytruda gave the answer that it is helpful for patients to use immuno-oncology for a certain period after surgery." “We are now able to take a step closer to the goal of complete cure with immuno-oncology,” he said.

 

Lee Se-hoon, professor at Samsung Seoul Hospital

The effects of immuno-anticancer drugs shown in clinical trials are being reproduced in the actual field.

 

Professor Lee explained, "When Gefitinib, the first EGFR-targeted anti-cancer drug, came out as a fellow in the past, I was very surprised that the prognosis of patients improved significantly.

 

I am feeling the emotions I felt then once again as I look at adjuvant therapy before and after immuno-anticancer drug surgery." He said, "The professors of the Department of Pathology were also surprised to see that there were so many 'cancer-free' cases when they did a PET scan after immuno-anticancer treatment.

 

Not only did the pathological CR increase, but I felt that the overall response improved." If Opdivo showed significant improvement in adjuvant therapy before surgery for the first time, Keytruda could improve the prognosis even for patients who have not reached complete pathological remission if they use immuno-anticancer drugs for one more year as adjuvant therapy after surgery.

 

Proven.

 

While the Opdivo study used only adjuvant therapy before surgery and there was no follow-up treatment after surgery, Keytruda's KEYNOTE-671 study used up to 4 cycles of Keytruda + chemotherapy on patients before surgery and performed Keytruda alone after surgery.

 

The design was designed to use up to 13 cycles of therapy.

 

Opdivo EFS and pathological pCR data (source BMS)

As a result of analyzing EFS, the primary endpoint, according to pathological complete remission status, EFS improved regardless of whether or not complete remission was achieved.

 

Patients who did not achieve pCR by administering immuno-anticancer drugs before surgery and administered Keytruda after surgery reduced the risk of disease recurrence, progression, or death by 31% compared to the control group.

 

Professor Lee said, "I knew that immunotherapy before surgery would be of great help from the Opdivo study, but there was no answer for postoperative treatment.

 

Because the clinical design was designed to use Opdivo only as an adjuvant therapy before surgery, Treatment was a situation where clinicians had to take care of themselves, so everyone was interested in how to treat patients who did not achieve complete remission.” The Keytruda study provided answers to questions raised in the clinical field.

 

Professor Lee said, “I was convinced through the KEYNOTE-671 study that the use of immuno-anticancer drugs after surgery is helpful even in the group that did not show pCR,” and “If you look at the EFS graph, the group that did not achieve pCR used Keytruda.

 

You can see that the graph is clearly wider than the group that did nothing."

EFS trend following pathological complete remission with Keytruda (data ASCO)

There are many aspects to be discussed about adjuvant therapy before and after surgery of immuno-anticancer drugs that have just begun to be used in the field.

 

Representative examples include use in patients with major mutations such as EGFR and ALK, and screening of patients who may experience difficulty in surgery with little improvement when using immuno-anticancer drugs before surgery.

 

However, he said, it is self-evident that immuno-anticancer drugs are being used for early lung cancer and are getting closer to the goal of a complete cure.

 

Professor Lee said, "The title of the 'ASCO' session, which included the KEYNOTE-671 research presentation, was 'The Promise of Neoadjuvant Immunotherapy Across Solid Tumors'.

 

As in the usual case, this study was not included in the lung cancer session.

 

Here, preoperative adjuvant immunotherapy for lung cancer You can notice the meaning of therapy.

 

It means that immuno-anticancer drugs have begun to actively intervene in the goal of complete recovery with adjuvant therapy before surgery.

 

I am happy to think that it has shown a major change in the cancer treatment paradigm."