Chicago Is So Back: Highlights from the 2024 ASCO Annual Meeting

Raymond Iannuccillo, PharmD, MBA, BCPS, BCOP, Sr. Medical Science Liaison – Rare Tumors, Early Assets, Hematology, Daiichi Sankyo, Inc

When I wasn’t sitting in the worst Chicago traffic I’ve ever seen or being amazed at the sheer number of people in the McCormick Convention Center, I was taking in all the spectacular data being presented at the 2024 ASCO Annual Meeting. The theme of ASCO this year was “The Art and Science of Cancer Care: From Comfort to Cure” and this year certainly lived up to the hype. The plenary session took place on Sunday, June 2nd, 2024 at 1:00 PM in the afternoon where five of the most impactful data sets were presented. Comfort and cure were well represented.

ESOPEC, presented by Dr. Jens Hoeppner from the University of Bielefeld, was a prospective randomized phase III trial comparing perioperative chemotherapy and surgery with fluorouracil, leucovorin, docetaxel, and oxaliplatin (FLOT protocol) against neoadjuvant chemoradiotherapy with paclitaxel, carboplatin, and radiation (CROSS protocol) followed by surgery in patients with curable, advanced esophageal adenocarcinoma. The primary endpoint in this trial was overall survival (OS). The study included 435 patients from 25 sites in Germany who were randomized to FLOT (N=221) or CROSS (N=217). After 403 patients started treatment with FLOT or CROSS, 371 patients completed surgery, and 351 patients achieved an R0 resection. Most patients were male (89.3%) with a median age of 63 years old (y/o) (range 30-86). Other baseline characteristics were well balanced between the arms. No new safety signals were identified. The median OS for the FLOT arm was 66 months (95% Confidence Interval (CI) 36 – not estimable) and 37 months (95% CI 28-43) for the CROSS arm. The 3-year OS rates were 57.4% (95% CI 50.1-64.0%) and 50.7% (95% CI 43.5-57.5%) (Hazard Ratio (HR)=0.70, 95% CI 0.53-0.92, p=0.012), respectively. A total of 35 patients (19.3%, 95% CI 13.9-25.9%) achieved a pathological complete response with FLOT versus 24 patients (13.5% 95% CI 8.8-19.4%) with CROSS. The results of the ESOPEC trial suggest that FLOT could become the new standard of care for advanced, resectable esophageal adenocarcinoma.

NADINA, presented by Dr. Christian Blank from the Netherlands Cancer Institute, was a randomized phase III trial comparing neoadjuvant nivolumab (Nivo) and ipilimumab (Ipi) with adjuvant nivolumab in patients with macroscopic, resectable stage III melanoma. Patients were randomized to receive Nivo+Ipi followed by standard of care therapeutic lymph node dissection (TLND) and adjuvant Nivo (or adjuvant BRAF/MEK inhibition for those tumors that were BRAF mutated) or TLND followed by adjuvant Nivo. The primary endpoint was event free survival (EFS) defined as the time from randomization to progression of disease, recurrence of disease, or death from melanoma or treatment. A total of 423 patients were enrolled on the trial with 212 patients having received neoadjuvant therapy and 211 patients having received adjuvant therapy. Within the neoadjuvant arm, 28 events occurred versus 72 events in the adjuvant arm, resulting in a HR of 0.32 (99.9% CI 0.15-0.66, p<0.0001). The 12-month EFS rate was 83.7% (99.9% CI 73.8-94.8) in the neoadjuvant group versus 57.2% (99.9% CI 45.1-72.6) in the adjuvant group. Systemic treatment related adverse events (AEs) that were grade 3 or greater occurred in 29.7% in the neoadjuvant group and 14.7% in the adjuvant group. These positive results of the NADINA trial suggest that neoadjuvant Nivo and Ipi can be considered the new standard of care in stage III melanoma.

COMPARATIVE effectiveness trial of early palliative care delivered via telehealth versus in person among patients with advanced lung cancer was presented by Dr. Joseph Greer from the Massachusetts General Hospital. Patients were randomized to receive early palliative care (EPC) either via telehealth or in person visits. The primary endpoint was to evaluate the equivalence of the effects of both modalities on quality of life (QoL) at week 24 with a +/- 4-point margin using the Functional Assessment of Cancer Therapy-Lung (FACT-L, range 0-136) assessment tool. Secondary outcomes included comparing rates of caregiver participation in EPC, patient reported depression and anxiety symptoms, coping, and perceptions of prognosis. A total of 1,250 patients were enrolled in the study across 22 sites in the United States. The median age was 65.5 years with 54% of patients being female and 82.1% of patients identifying as white. The QoL adjusted mean scores were 99.67 in the telehealth group and 97.67 in the in-person group (p<0.043 for equivalence). Caregiver participation was lower in the telehealth group (36.6%) compared to the in-person group (49.7%, p<0.0001). The two groups were equivalent in patient reported depression and anxiety symptoms, coping, and perceptions of prognosis. The results of this trial highlight the potential of telehealth as a modality to improve access to EPC.

LAURA, presented by Dr. Suresh Ramalingam from the Winship Cancer Institute, was a 2:1 randomized, phase III placebo-controlled trial evaluating the use of osimertinib (Osi) or placebo in unresectable stage III epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC) without progression after definitive chemoradiotherapy (CRT). The primary endpoint was progression-free survival (PFS) by blinded independent central review (BICR). Secondary endpoints included OS and safety. A total of 216 patients were enrolled on the trial with 143 patients receiving Osi and 73 patients receiving placebo. Patient characteristics were generally well balanced between the groups. Median PFS was 39.1 months (95% CI 31.5-not calculable) in the Osi group versus 5.6 months (95% CI 3.7-7.4) in the placebo group. The HR for PFS was 0.16 (95% CI 0.1-0.24, p<0.001). The 12- and 24-month PFS rates were 74% and 65%, respectively, for Osi and 22% and 13%, respectively, for placebo. The OS HR was0.81 (95% CI 0.42-1.56), while immature, showed a trend favoring Osi. It is important to note that 81% of placebo patients received Osi after progression. AEs greater than or equal to grade 3 (35% versus 12%), serious AEs (38% versus 15%), radiation pneumonitis (48% versus 38%), and AEs leading to discontinuation (13% versus 5%) were all higher in the Osi group compared to placebo.. The results of the LAURA trial support Osi becoming the new standard of care in patients with unresectable stage III EGFRm NSCLC.

ADRIATIC, presented by Dr. David Spigel from the Sarah Cannon Research Institute, was a phase III, randomized, double-blind, placebo-controlled trial evaluating durvalumab (D) +/- tremelimumab (T) versus placebo consolidation in limited stage small cell lung cancer (LS-SCLC) who had not progressed after chemoradiotherapy. Patients were randomized 1:1:1 to D + placebo, D + T, or placebo + placebo. This presentation was the first look at the interim analysis of the D versus placebo. The trial had dual primary endpoints of OS and PFS by BICR for D versus placebo. Secondary endpoints included OS and PFS by BICR for D + T versus placebo. Of the 730 patients that were randomized to the trial, 264 patients received D and 266 patients received placebo. Patient baseline characteristics were well balanced between the arms. OS (HR=0.73, 95% CI 0.57-0.93, p<0.0104) and PFS (HR=0.76, 95% CI 0.61-0.95, p<0.0161) were significantly improved in the D arm versus placebo. Median OS and PFS were 55.9 months (95% CI 37.3-not estimable) and 16.6 months (95% CI 10.2-28.2) for the D arm versus 33.4 months (95% CI 25.5-39.9) and 9.2 months (95% CI 7.4-12.9) in the placebo arm, respectively. There were no new safety signals identified, although AEs that lead to discontinuation (16.3% versus 10.6%) and any grade pneumonitis (38.0% versus 30.2%) were higher in the D arm versus the placebo arm. These interim results of ADRIATIC support a durvalumab-based regimen as consolidation therapy in LS-SCLC and should be considered standard of care for these patients.

As I reflect on ASCO 2024, I’m humbled by the progress we have made in the last year, but I know that we still have a lot of work left to do. I look forward to the ASCO 2025, where we’ll hopefully continue to push the boundaries of what’s possible in cancer care.

Save the Date: ASCO’s 2025 annual meeting will be held May 30th to June 3rd, 2025; More information is available on their website: www.asco.org

References

1.Hoeppner J, Brunner T, Lordic F, et al. Prospective randomized multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (ESOPEC trial). J Clin Oncol. 2024;42(suppl;abstr LBA1)

2.Blank C, Lucas M, Scolyer R, et al. Neoadjuvant nivolumab plus ipilimumab versus adjuvant nivolumab in macroscopic, resectable stage III melanoma: The phase 3 NADINA trial. J Clin Oncol. 2024;42(suppl;abstr LBA2)

3.Greer J, Trotter C, Jackson V, et al. Comparative effectiveness trial of early palliative care delivered via telehealth versus in person among patients with advanced lung cancer. J Clin Oncol. 2024;42(suppl;abstr LBA3)

4.Ramalingam S, Kato T, Ahn M, et al. Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable stage (stg) III epidermal growth factor receptor-mutated (EGFRm) NSCLC: Primary results of the phase 3 LAURA study. J Clin Oncol. 2024;42(suppl;abstr LBA4)

5.Spigel D, Cheng Y, Cho B, et al. ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). J Clin Oncol. 2024;42(suppl;abstr LBA5)