Assessing 2024 Oncology Advances and Looking Ahead

Neil M. Iyengar, MD, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medicine, New York, NY

The field of oncology continues to evolve rapidly, with transformative advances in 2024 offering novel diagnostic and therapeutic options. Below are some of the most impactful advances from 2024, which span various cancer types, therapeutic approaches, and treatment settings.

First, we have seen new and improved liquid biopsy assays with high sensitivity for the detection and sequencing of circulating tumor DNA (ctDNA). These improvements in ctDNA detection and profiling have short- and long-term impacts. In the short term, higher sensitivity assays can identify more patients who may benefit from precision oncology treatment approaches. Longer-term impact is anticipated from ongoing clinical trials that incorporate highly sensitive assays to test strategies for escalating or de-escalating cancer treatment based on ctDNA dynamics. Second, another area of rapid advancement is the use of artificial intelligence (AI) and machine learning for early detection, diagnosis, and even treatment. Diagnostic tools, such as mammography and cross-sectional imaging, are increasingly driven by AI because of progress in machine learning algorithms. In the treatment setting, AI-based tools are increasingly incorporated into precision oncology clinical trials for the matching of candidate tumors with targeted therapeutics. Another key priority that has significantly advanced in the past year is quality of life and patient-reported outcomes. Results of several studies now demonstrate that early incorporation of whole-person care—including diet, exercise, and integrative therapies—significantly improves overall quality of life and specific parameters such as fatigue and pain. To have a public health impact, the growing evidence supporting lifestyle interventions in oncology needs to be leveraged for policy-making and reimbursement to optimize accessibility.

In the past year, several notable advancements were made in medical therapies that increase tumor response, decrease recurrence risk, and improve survival. For example, in early-stage breast cancer with an elevated risk of recurrence, the CDK4/6 inhibitor ribociclib (Kisqali) received FDA approval based on results from the adjuvant phase 3 NATALEE trial (NCT03701334).¹ The indication for adjuvant ribociclib includes patients with high-risk N0 breast cancer, a notable advance for patients who have discordant risk stratification by anatomic staging vs histologic and/or genomic assessment.

Another CDK4/6 inhibitor, abemaciclib (Verzenio), was approved for adjuvant use in 2023. Longer-term follow-up data from the phase 3 monarchE trial (NCT03155997), which were presented in 2024, demonstrated that invasive disease-free survival benefit could be maintained in patients with high-risk early-stage breast cancer.²

Data supporting the use of novel antibody-drug conjugates (ADCs) and extended use of approved ADCs across various cancer types and treatment settings were released in 2024. For example, new data were presented supporting earlier use of trastuzumab deruxtecan (T-DXd; Enhertu) in hormone receptor–positive, HER2-low metastatic breast cancer and for HER2 ultralow tumors. In 2024, T-DXd was also approved for use in gastric or gastroesophageal junction adenocarcinoma with HER2 overexpression and accelerated approval for unresectable or metastatic HER2-positive tumors.³

Other important drug approvals in 2024 were seen in immunotherapy and molecular therapeutics. For example, the ADC tisotumab vedotin-tftv (Tivdak) received full approval in 2024 for the treatment of recurrent or metastatic cervical cancer. The full approval was based on data confirming an overall survival benefit in the phase 3 innovaTV 301 trial (NCT04697628).⁴ Immunotherapy in primary advanced or recurrent endometrial cancer treatment was expanded in 2024 to include the use of PD-1 inhibitors pembrolizumab (Keytruda) or dostarlimab-gxly (Jemperli) with carboplatin and paclitaxel followed by single-agent immunotherapy (agnostic to mismatch repair or microsatellite instability status). Immunotherapy for lung cancer was also advanced, including approval for durvalumab (Imfinzi) plus chemotherapy for resectable non–small cell lung cancer (NSCLC).⁵

Impactful molecular therapeutics also approved in 2024 included lazertinib (Leclaza) plus amivantamab-vmjw (Rybrevant) for the first-line treatment of locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21
L858R substitution mutations based on results from the phase 3 MARIPOSA trial (NCT04487080).⁶ Other important molecular therapy approvals in 2024 include selpercatinib (Retevmo) for RET-mutated medullary thyroid cancer and repotrectinib (Augtyro) for NTRK gene fusion–positive solid tumors. Finally, intriguing preliminary data emerged in 2024 supporting the hypothesis that metabolic interventions, such as glucagon-like peptide 1 agonists, have anticancer potential.

The rapid pace of discovery and innovation in oncology accelerated in 2024. Results from ongoing or planned trials addressing toxicity management (including financial toxicity), optimal therapeutic sequencing, access, and disparities mitigation are eagerly anticipated.

References

1. FDA approves ribociclib with an aromatase inhibitor and ribociclib and letrozole co-pack for early high-risk breast cancer. News release. FDA. September 17, 2024. Accessed November 14, 2024. https://shorturl.at/pXFP0
2. FDA expands early breast cancer indication for abemaciclib with endocrine therapy. News release. FDA. March 3, 2023. Accessed November 14, 2024. https://shorturl.at/hnzNS
3. FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. News release. FDA. April 5, 2024. Accessed November 14, 2024. https://shorturl.at/MCI27
4. FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. News release. FDA. April 29, 2024. Accessed November 14, 2024. https://shorturl.at/E8iGu
5. FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer. News release. FDA. August 15, 2024. Accessed November 14, 2024. https://shorturl.at/06Val
6. FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer. News release. FDA. Updated August 20, 2024. Accessed November 14, 2024. https://shorturl.at/5N0Ny