2023-07-03| Special

2023 ASCO Annual Meeting: Progress in Solid Tumor Treatment Research, and Promising Results in Emerging Therapies

by Richard Chau
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Every June, the American Society of Clinical Oncology (ASCO) holds its annual meeting in Chicago, Illinois, at which leading oncologists, researchers, public officials, patient advocates, investors, and biopharma companies gather to discuss key issues such as cancer prevention and therapies, new drug development, and cancer patient care, in addition to presenting a number of significant research findings and clinical results.

From June 2 to 6, the world’s largest cancer conference returned in full swing after 3 years of the COVID-19 pandemic. Apart from virtual broadcasts, the event has largely shifted back to in-person attendance. The 2023 ASCO Annual Meeting brought together over 42,000 oncology professionals from 158 countries, about 36,000 of them in-person in Chicago. GeneOnline’s editorial team has compiled some significant announcements and key research presentations from across the conference, including new discoveries in oncology and cancer therapies, plus relevant clinical applications.

Related article: 2023 ASGCT Annual Meeting: Showcase of Exciting New Research, with a Focus on Clinical Applications 

Emphasis on the Clinician-Patient Partnerships in Cancer Care and Research

Chosen by 2022-2023 ASCO President Dr. Eric P. Winer, the theme for this year’s Annual Meeting is “Partnering with Patients: The Cornerstone of Cancer Care and Research”, which reinforced the necessary and crucial role people living with cancer have in scientific research. Not only did it encourage attendees to examine how clinicians and patients have interacted over the years, but it also emphasized the significance of reviewing what has improved, what has deteriorated, and what could be done to bring about a better clinician-patient relationship.

According to Dr. Winer, building stronger clinician-patient partnerships would be important in better patient experiences and career fulfillment for clinicians. In his Presidential Address in the Opening Session, he urged healthcare workers to listen to patients’ needs, involve patients as partners in cancer research, and protect them from stigmatization. Also, he pointed out that strong partnerships between patients and clinicians would be beneficial in many ways, including recruitment of patients to participate in clinical trials, improvement of patients’ overall quality of life, and mitigation of cancer care disparities faced by marginalized groups such as the LGBTQ+ community, racial and ethnic minorities, and those living in poverty or with mental health challenges.

To amplify the patient voice, the ASCO 2023 Annual Meeting included the groundbreaking patient forum that not only allowed patients and advocates to discuss unmet needs and expectations, but also focused on generating solutions and driving change in the cancer community. Regarding the maintenance of clinicians’ well-being, there was an educational session that highlighted evidence-based solutions to reduce professional burnout.

HER2-expressing Solid Tumors: AstraZeneca and Daiichi Sankyo’s Unveiled Encouraging Results

HER2 protein is a receptor tyrosine kinase and regulates cellular proliferation and growth. Its overexpression in cancers often links with aggressive disease and poor prognosis. At the ASCO 2023 Annual Meeting, AstraZeneca and Daiichi Sankyo presented results from an interim analysis of the ongoing Phase 2 DESTINY-PanTumor02 trial, evaluating the efficacy and safety of Enhertu (5.4mg/kg), an engineered HER2-directed antibody-drug conjugate (ADC) for the treatment of previously treated HER2-expressing tumors such as biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, as well as metastatic colorectal cancer. 

With reference to the data presented by the two big pharma companies, Enhertu showed an objective response rate (ORR) of 37.1% in the overall population (37.8% for colorectal cancer). The median duration of response (DoR) was 11.8 months (5.5 months for colorectal cancer). Also, nearly half (49.6%) of all participating patients who achieved a response remained in response at one year. The safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified. According to these findings, HER2 expression can be targeted in a wide variety of tumor types, and Enhertu may be beneficial to specific patients with HER2-expressing advanced solid tumors who currently have limited treatment options and a poor prognosis.

Non-Small Cell Lung Cancer (NSCLC): Positive Results Released as New Drugs Effectively Prolong Survival

Comprising 80-85% of all lung cancer cases worldwide, NSCLC is also an R&D hot spot for major pharmaceutical companies. At the ASCO 2023 Annual Meeting, there were also multiple encouraging clinical data presentations related to NSCLC drugs. For example, Merck (known as MSD outside of the United States and Canada) unveiled the first-time data from the pivotal Phase 3 KEYNOTE-671 study evaluating pembrolizumab (KEYTRUDA), an anti-PD1 immune checkpoint inhibitor, in the perioperative setting for resectable stage II, IIIA or IIIB NSCLC. Moreover, AstraZeneca announced results from the Phase 3 ADAURA study assessing the efficacy of osimertinib (Tagrisso), a small-molecule oral EGFR inhibitor, in treating early-stage (IB, II and IIIA), EGFR-mutated (EGFRm) NSCLC in the adjuvant setting. 

Merck’s presentation showed that both the addition of pembrolizumab to platinum-based chemotherapeutics as neoadjuvant therapy followed by resection and the use of adjuvant pembrolizumab 4-12 weeks after surgery could provide a statistically significant and clinically meaningful improvement in event-free survival (EFS) and major pathologic response (mPR). Based on AstraZeneca’s Phase 3 data, Tagrisso achieved an unprecedented overall survival rate in patients with early-stage EGFRm NSCLC with 88% of participants alive at five years.

Unresectable Hepatocellular Carcinoma (uHCC): Anti-TIGIT Antibody Improves Response of First-line Treatment

The combination of monoclonal antibodies atezolizumab and bevacizumab is currently the current first-line standard of care treatment for patients with uHCC, with satisfactory efficacy proven in the Phase 3 IMbrave150 study in 2020. Based on this success, researchers are actively investigating whether incorporating an anti-TIGIT antibody into the existing treatment can improve its responses. During the 2023 ASCO Annual Meeting, Dr. Richard S. Finn of the University of California, Los Angeles (UCLA) presented the MORPHEUS-Liver data, which assessed the efficacy and safety of the addition of Roche’s anti-TIGIT tiragolumab to the atezolizumab–bevacizumab duo in treating uHCC.

According to the latest results of this Phase 1b/2 study involving 58 uHCC patients, when compared to using the atezolizumab–bevacizumab duo alone, the antibody triplet achieved a significantly higher ORR (42.5% vs. 11.1%) and a longer median progression-free survival (11.1 months vs. 4.2 months) without new safety signals identified. These data suggested anti-TIGIT treatment may be a potential enhancer of existing checkpoint inhibitors, opening up possibilities in developing a more effective first-line treatment option for patients with uHCC.

Early-stage Breast Cancer: Intense Market Rivalry Between Novartis and Eli Lilly Awaits

Hormone receptor-positive/human epidermal growth factor receptor-negative (HR+/HER2-) breast cancer is the most common subtype of the disease, making up nearly 70% of all breast cancer cases in the U.S. At the previous ASCO Annual Meeting, Novartis presented overall survival (OS) and quality of life (QoL) analyses which evaluated ribociclib (Kisqali) in treating advanced or metastatic HR+/HER2- breast cancer. Data from the Phase 3 MONALEESA-2 study showed that this small-molecule oral CDK 4/6 inhibitor, in conjunction with endocrine therapy, had consistently shown statistically significant overall survival. 

This year, the Swiss pharma giant intended to expand Kisqali’s presence in breast cancer treatment by presenting clinical results of an early breast cancer trial at the world’s biggest stage of clinical oncology. According to the primary endpoint data from the pivotal Phase 3 NATALEE trial, compared with hormonal therapy alone, combining Kisqali and endocrine therapy after surgery reduced the risk of invasive tumor recurrence or death by 25% in patients with early HR+/HER2- breast cancer (Stage II and III) after a median follow-up of 34 months. Besides, the Kisqali group achieved a 90.4% 3-year invasive disease-free survival (iDFS) rate,  compared to 89.9% for the group using endocrine therapy alone.

Spherical Insights LLP published a study this April, indicating that the global breast cancer market size will increase from $31.9 billion to $85.5 billion in the next 10 years at a compound annual growth rate of 10.3%. In particular, therapeutics for early-stage breast cancer are expected to constitute a much larger portion of the market. In this multi-billion dollar early breast cancer market, one of Novartis’ top competitors is abemaciclib (Verzenio) developed by Eli Lilly, another small molecule oral CDK 4/6 inhibitor. At the 2023 ASCO Annual Meeting, Lilly also presented clinical data on Verzenio’s efficacy and safety in treating early HR+/HER2- breast cancer that has spread to the lymph nodes (node-positive).

According to results from the Phase 3 monarchE trial, Verzenio, combined with endocrine therapy, reduced the risk of invasive disease by 29% with a tolerable safety profile after a median follow-up of 19 months. The effect widened to 35% after nearly four years of follow-up. In addition, 92.7% of patients who took Verzenio were alive without invasive disease at two years, compared to 89.9% in the control group using endocrine therapy alone.

In 2022, Kisqali and Verzenio had total sales of $1.23 billion and $2.48 billion respectively, both experiencing substantial growth compared to 2021. Already direct competitors in the market for advanced or metastatic breast cancer, the two CDK4/6 inhibitors are expected to engage in a heated rivalry in the early-stage breast cancer market, according to data presented by Novartis and Lilly at the ASCO meeting. 

Regarding this indication area, it is noteworthy that Novartis is eyeing a wider patient population, covering both high-risk and intermediate-risk patients. Currently Verzenio only has the approval for treating patients with cancer affecting the lymph nodes, whereas Novartis, which plans to file for FDA approval for Kisqali in the second half of 2023, also targets node-negative patients. In a recent interview, Vas Narasimhan, CEO of the Swiss pharma giant, commented “we think this will allow us to access a very large market, double the size of any of our competitors and really make this (Kisqali) into one of the largest medicines of Novartis’ portfolio.”

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