ASCO Annual Meeting 2019: Immunotherapy for Lung Cancer, Gastrointestinal Cancers and Targeted Therapy for Breast Cancer

2019 ASCO ® Annual Meeting; #ASCO19
June 1, 2019
Monika Sharda, ASCO staff

The theme of the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting is Caring for Every Patient, Learning from Every Patient. For the past year, ASCO President Monica M. Bertagnolli, MD, FACS, FASCO, has visited local groups across the United States to learn what patients and doctors truly experience when receiving and providing cancer care. As she writes in this year’s Clinical Cancer Advances report, “Cancer treatment advances are only as good as patients’ ability to access them.” This year’s ASCO Annual Meeting strikes the balance in Dr. Bertagnolli’s theme, bringing late-breaking research news to the public and exploring the ways that access to cancer care can be improved for patients.share on twitter

More than 32,000 oncology professionals from around the world are at the ASCO Annual Meeting in Chicago, presenting and discussing the latest research in cancer treatment and patient care. Learn about the research released today:

  • Pembrolizumab improves survival for some people with advanced non-small cell lung cancer

  • Pembrolizumab is an effective option for some people with advanced stomach and gastroesophageal junction cancers

  • Adding ribociclib to hormonal therapy lengthens lives of premenopausal women with advanced breast cancer

Watch a patient education video with Dr. Bertagnolli explaining how the ASCO Annual Meeting changes patients’ lives.

Studies find immunotherapy may work better as first treatment for some people with advanced non-small cell lung cancer, gastrointestinal cancersshare on twitter

Pembrolizumab (Keytruda) is an immunotherapy that has been approved by the U.S. Food and Drug Administration (FDA) for several advanced and metastatic cancers. The medicine works by blocking a protein on the surface of cancer cells called PD-L1, allowing the body’s immune cells to destroy the cancer. Two recent studies suggest that treatment changes with pembrolizumab can help some people with non-small cell lung cancer (NSCLC), stomach cancer, and gastroesophageal junction cancer live longer, with the possibility of less side effects.

Pembrolizumab improves survival for some people with advanced non-small cell lung cancer

A phase I clinical trial called KEYNOTE-001 showed that some people with advanced NSCLC who received pembrolizumab lived 3 to 4 times longer than expected.share on twitter Pembrolizumab can be used as a first treatment or as a second treatment after chemotherapy for NSCLC when a tumor makes PD-L1.

This study included 550 participants with advanced NSCLC. Most (449) had previously received another treatment before starting pembrolizumab. The remaining people (101) had not received another treatment. For this study, all the participants started receiving pembrolizumab every 2 or 3 weeks, depending on their body weight. Then, they continued taking it only every 3 weeks.

Among the patients who had not received previous treatment, 23% were alive after 5 years. Almost 16% of those who had previous treatment were alive after 5 years. For comparison, before the development of immunotherapy, less than 6% of people with metastatic NSCLC lived at least 5 years.

The researchers also found that people who had tumors with a higher level of PD-L1 lived longer. They found the following after 5 years:

  • Among the people who had not received any treatment before pembrolizumab, almost 30% of those with a high PD-L1 level were alive compared with about 16% of those with a lower PD-L1 level.

  • Among the people who had previously received treatment, 25% of those with a high PD-L1 level were alive compared with nearly 13% of those with a lower PD-L1 level.

  • Less than 4% of people treated previously and with a very low PD-L1 level were alive.

In this study, 17% of participants experienced immune-related side effects. The most common was hypothyroidism, which is when the immune system attacks the body’s thyroid gland leading to slower thyroid function. Pneumonitis, or inflation of lung tissue, was the most serious side effect, but it was uncommon.

What does this mean? Previous research has shown that pembrolizumab is effective for treating NSCLC. This study suggests that this treatment can also improve survival, especially for people who have not had a previous treatment and have cancer with a high level of PD-L1.

“The uniformly negative outlook that has been associated with a diagnosis of advanced non-small cell lung cancer is certainly no longer appropriate. The fact that we have patients on this trial that are still alive after 7 years is quite remarkable. We also have evidence that most patients who are doing well after 2 years on pembrolizumab live for 5 years or more.

—   lead study author Edward B. Garon, MD, MS
UCLA
Los Angeles, California

Pembrolizumab is an effective option for some people with advanced stomach and gastroesophageal junction cancersshare on twitter

A phase III clinical trial called KEYNOTE-062 found that initial, or front-line, treatment with pembrolizumab for people with advanced stomach cancer or gastroesophageal junction (GEJ) cancer may be as effective as chemotherapy, which is currently the standard treatment, and cause fewer side effects. The GEJ is where the stomach joins the esophagus. Pembrolizumab is currently approved for people with advanced stomach and GEJ cancer whose tumors make PD-L1.

This study included 763 people with advanced human epidermal receptor 2 (HER2)-negative stomach or GEJ cancer. HER2 is a protein found on the surface of cancer cells. When a cancer has low levels of this protein, it is called HER2-negative. Previous research has shown that HER2-negative tumors have a higher chance of coming back after treatment.

The study participants received 1 of 3 initial treatments for up to 2 years:

  • Pembrolizumab

  • Pembrolizumab plus chemotherapy

  • Chemotherapy plus a placebo. A placebo is an inactive drug.

The researchers analyzed the level of PD-L1 in the tumor by using a scoring method called combined positive score (CPS). CPS predicts how much people with stomach or GEJ cancer may benefit from pembrolizumab. Previous studies have shown that a CPS of 1 or more is linked with a possible benefit from pembrolizumab. Scores of 10 or more are linked with a higher chance of pembrolizumab being effective.

Among people with a CPS of 10 or more, 39% of those given pembrolizumab only were alive after 2 years, compared with 22% of those who received chemotherapy only. The median overall survival was about 17 months for those who received pembrolizumab alone, compared with about 11 months for those who received chemotherapy alone. The median is the midpoint, which means that half of the people lived longer and half lived a shorter time.

There was no noticeable difference in survival between those 2 treatments in people with a CPS less than 10, suggesting that both pembrolizumab and chemotherapy are good options for people with a lower CPS.

The effectiveness of chemotherapy and pembrolizumab combined is still being analyzed, but early results show that it is similar to treatment with chemotherapy alone, regardless of the CPS.

Overall, pembrolizumab caused less serious effects than chemotherapy. Severe side effects, including nausea and fatigue, were most common for people taking a combination of the treatments (73%), followed by those only receiving chemotherapy (69%), and pembrolizumab (17%).

What does this mean? People with stomach or GEJ cancer that has a high PD-L1 level may benefit more from pembrolizumab as a first treatment rather than chemotherapy.share on twitter

“This trial shows that front-line pembrolizumab is effective and could provide a new opportunity for people newly diagnosed with advanced gastric or gastroesophageal junction cancers. There remains a significant unmet need for treatments for these cancers and our results reinforce the importance of continued research in this field.”

—   lead study author Josep Tabernero, MD, PhD
Vall d’Hebron University Hospital and Institute of Oncology
Barcelona, Spain 

Adding ribociclib to hormonal therapy lengthens lives of premenopausal women with advanced breast cancer

A phase III clinical trial called MONALEESA-7 found that adding ribociclib (Kisqali) to hormonal therapy helped women with advanced breast cancer who have not been through menopause live longer. Hormonal therapy, also called endocrine therapy, lowers the levels of hormones that the cancer uses to grow. Ribociclib is a type of targeted therapy that targets a protein in breast cancer cells called CDK4/6, which may stimulate cancer cell growth. 

The 672 women who participated in the study had hormone receptor-positive, HER2-negative advanced breast cancer, were younger than 59, and had not been through menopause. They had also not been treated with hormonal therapy previously. Advanced breast cancer is less common in premenopausal women. However, the number of women developing this cancer at a younger age has been increasing.

The study participants received either ribociclib or a placebo (an inactive drug), and all women received initial, or first-line, treatment with 2 types of hormonal therapy:

  • Goserelin (Zoladex), a type of hormonal therapy given by injection that stops the ovaries from making estrogen for 1 to 3 months.

  • An aromatase inhibitor (AI) or tamoxifen (Soltamox). AIs block an enzyme that helps make estrogen and include letrozole (Femara) or anastrozole (Arimidex). Tamoxifen blocks estrogen from binding to breast cancer cells.

Researchers found that the women who received ribociclib lived a median of almost 2 years without the disease getting worse, compared with about 1 year for women who did not. The median is the midpoint, which means that half of the patients lived longer without the disease worsening and half lived for a shorter time. After more than 3 years, 70% of women taking ribociclib were alive, compared with 46% of women who did not. Overall, the women who took ribociclib with the hormonal therapy were 29% less likely to die from breast cancer than the women who received the hormonal therapy with the placebo.

The effectiveness of ribociclib was almost the same whether it was given with letrozole, anastrozole, or tamoxifen.

What does this mean? Adding ribociclib to hormonal therapy may help extend the lives of women diagnosed before menopause with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.share on twitter

“This is the first study to show improved survival for any targeted therapy when used with endocrine therapy as a first-line treatment for advanced breast cancer. The use of ribociclib as a front-line therapy significantly prolonged overall survival, which is good news for women with this terrible disease.

—   lead study author Sara A. Hurvitz, MD
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California

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