Notable ASCO Trial Data Have the Potential to Transform Oncology Pharmacy Practice

The American Society of Clinical Oncology (ASCO) Annual Meeting provides updates on top international oncology research in the field. In 2023, the meeting featured over 200 sessions with more than 42,000 attendees.

Each year, findings from trial data are presented that have the potential to not only inform and educate clinical oncology practice, but also impact and even transform the landscape of the field. This year was no different.

NATALEE Trial

Some of the most impactful data presented at this year’s meeting were in the use of the CDK4/6 inhibitor ribociclib (Kisqali; Novartis). Data were presented by Dennis J. Slamon, MD, PhD, and colleagues (abstract LBA500) from the phase 3, multi-center, randomized, open-label NATALEE trial (NCT03701334), showing that adding ribociclib to endocrine therapy resulted in a significant improvement in invasive disease-free survival for patients with hormone receptor–positive (HR+)/HER2-negative early-stage breast cancer (90.4% vs 87.1% in the hormonal-only arm).

While ribociclib has previously shown survival benefits in people with metastatic disease, NATALEE study findings showed that it may also improve outcomes for people with earlier-stage disease, including those with cancer that has not spread to the lymph nodes.¹

HERIZON-BTC-01 Trial

The global phase 2 HERIZON-BTC-01 trial (NCT04466891) showed that zani-datamab (Zymeworks), a potential new HER2-targeted bispecific antibody, has demonstrated durable responses in patients with treatment-refractory HER2+ biliary tract cancer. Data showed a confirmed objective response rate (ORR) of 41% at a median duration of response (mDOR) of 12.9 months. This is significantly higher than standard chemotherapy, which is generally only approximately 5%, according to trial lead Shubham Pant, MD, MBBS, associate professor in the Department of Gastrointestinal Medical Oncology with a joint appoint-ment in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.²

DUO-O Trial

The combination of the oral PARP inhibitor olaparib (Lynparza; AstraZeneca) and durvalumab (Imfinzi; Medimmune/Astra-Zeneca) in standard care has demonstrated improved progression-free survival (PFS) in newly diagnosed patients with advanced ovarian cancer without a BRCA mutation, according to results from the DUO-O study (NCT03737643). Study findings presented as abstract LBA5506 revealed a median PFS (mPFS) of 37.3 months (vs 23 months) and a decreased risk of disease progression, regardless of homologous recombination deficiency (HRD) status.³

MIRASOL Trial

In ovarian cancer, the results of the phase 3 MIRASOL study (NCT04209855), presented as abstract LBA5507, demonstrated an improved PFS (5.62 vs 3.98 months), ORR (42.3% vs 15.9%), and median overall survival (OS; 16.46 vs 12.75 months) in patients with recurrent platinum-resistant ovarian cancer with a high expression of folate receptor α when treated withmirvetuximab (Elahere; ImmunoGen) vs investigator’s choice.⁴

THOR Trial

Data from the phase 3 THOR trial (NCT03390504) were presented, demonstrating significant improvement of both PFS and OS in patients with FGFR-mutated advanced urothelial carcinoma when treated with erdafitinib (Balversa; Janssen) vs investigator’s choice of chemotherapy. OS was 12.1 months (vs 7.8 months) and mPFS was 5.6 months (vs 2.7 months).⁵

INDIGO Trial

The phase 3 INDIGO study (NCT04164901) showed that the oral, dual IDH1/2 inhibitor vorasidenib (AG-881; Servier Pharmaceuticals) significantly improved PFS in patients with grade 2 gliomas. The data demonstrated a 27.7-month PFS (vs 11.1 months in the placebo arm) as well as a delay in time to next treatment (not reached [NR] vs 17.4 months).⁶

ADAURA Trial

Final OS data were presented from the ADAURA trial (NCT02511106), demonstrating a 50% reduction in risk of death for patients with EGFR-mutated NSCLC treated with osimertinib (Tagrisso; AstraZeneca) vs placebo. This OS benefit was seen across all patient subgroups including patients with stage IB, II, or IIIA cancer and in patients who did not receive prior adjuvantchemotherapy. Additionally, 66% of patients completed 3 years of treatment (vs 41% placebo) and only 22% of patients on osimertinib went on to receivesubsequent anticancer treatment compared with 54% of those on placebo.⁷

MonumenTAL-1 Trial

Abstracts 8036, 8020, and 8003 highlighted the follow-up phase 1/2 MonumenTAL-1 trial that showed the ORR, safety, and efficacy data of the investigational bispecific antibody talquetamab (Janssen) for the treatment of patients with relapsed or refractory (R/R) multiple myeloma (MM). Data showed ORR was 71.7% at 12.7 months, mDOR was not reached and 9.5 months, and 12-month median OS was 77.4% and 76.4% (twice weekly and weekly dosing, respectively).⁸

RedirecTT-1 Trial

Janssen also revealed the results of the phase 1b RedirecTT-1 study (NCT04586426), presented as abstract 8002, which combined the bispecific antibodies teclistamab-cqvv (Tecvayli; Janssen) and talquetamab to achieve an 86.6% ORR in all patients with R/R MM and 96.3% in patients with R/R MM using the phase 2 regimen (RP2R[s]).^8,9

TALAPRO-2 Trial

The phase 3 TALAPRO-2 trial (NCT03395197), presented as abstract 5004, added talazoparib (Talzenna; Pfizer) to enzalutamide (Xtandi; Astellas Pharma) in the first-line setting for patients with BRCA-mutated metastatic castration-resistant prostate cancer. The data showed an mPFS that was not reached (vs 13.8 months in the enzalutamide arm) and a 55% reduced risk of progression or death in the HRD arm.¹⁰

A Global Initiative to Improve Global Patient Access to Oncolytics

Established in 2022, the Access to Oncology Medicines Coalition was presented at the conference and discussed as the opportunity to work internationally to reduce the burden of cancer on patients living in low- to middle-income countries by improving access to oncology medications and diagnostic tools. The coalition identified 46 countries that need greater access to services and medications and discussed its plans to work to reduce the significantly greater incidence of cancer-related deaths in these regions.^11,12

References

1. ASCO Post Staff. Adding Ribociclib to Endocrine Therapy May Reduce Recurrence Risk in Patients with Hormone Receptor–Positive, HER2-Negative Early-Stage Breast Cancer. ASCOPost.com. https://ascopost.com/news/june-2023/adding-ribociclib-to-endocrine-therapy-may-reduce-recurrence-risk-in-patients-with-hr-positive-her2-negative-early-stage-breast-cancer/.Last Updated June 2, 2023. Accessed June 13, 2023.
2. Larry Kimmons. ASCO: Targeted therapy induces responses in HER2-amplified biliary tract cancer. MD Anderson Newsroom. https://www.mdanderson.org/newsroom/asco-targeted-therapy-induces-responses-her2-amplified-biliary-tract-cancer.h00-159619434.html. Last Updated June 2, 2023. Accessed June 13, 2023
3. Aaron Tallent. Durvalumab Plus Olaparib “Huge Step Forward” in Advanced Ovarian Cancer Survival. OBR Oncology: ASCOE Conference Coverage. https://www.obroncology.com/article/durvalumab-plus-olaparib-huge-step-forward-in-advanced-ovarian-cancer-survival?ap=nl2101&rhid=VHBR00317219074&mkt_tok=NTQxLUdLWi0yNDMAAAGMIY9clY9Roy72MrPJQQqVXB0bjGlMPByA2s81THmUgDu6kd1BhMK_pwaFLljpDzAhnk3oSubISTBpNiBN8. Last Updated June 3, 2023. Accessed June 13, 2023.
4. Sara Fagerlie, PhD, CHCP. ASCO Conference Coverage: Practice-Changing Results in Platinum-Resistant Ovarian Cancer, as Mirvetuximab Boosts Survival. OBR Oncology: ASCO Conference Coverage. https://www.obroncology.com/article/practice-changing-results-in-platinum-resistant-ovarian-cancer-as-mirvetuximab-boosts-survival. Last Updated June 4, 2023. Accessed June 13, 2023.
5. Emily Kuhl, PhD. THOR: Survival Benefit Seen With Erdafitinib in Advanced Urothelial Carcinoma. ASCO Daily News. https://dailynews.ascopubs.org/do/thor-survival-benefit-seen-erdafitinib-advanced-urothelial-carcinoma.Last Updated June 5, 2023, Accessed June 13, 2023.
6. ASCO Staff. Vorasidenib Delays Disease Progression or Death in Patients With Grade 2 IDH-Mutated Glioma. ASCO Post News. https://ascopost.com/news/june-2023/vorasidenib-delays-disease-progression-or-death-in-patients-with-grade-2-idh-mutated-glioma/?utm_source=TAP%2DEN%2D060423&utm_medium=email&utm_term=d959aa38b17f132c7c3a9c8ac701dbbf. Last Updated June 4, 2023. Accessed June 13, 2023
7. Kara Nyberg, PhD. Final ADAURA OS Analysis Reinforces Adjuvant Osimertinib as a Standard of Care for Patients With Stage IB to IIIA EGFR-Mutated Non–Small Cell Lung Cancer. ASCO Daily News. https://dailynews.ascopubs.org/do/final-adaura-os-analysis-reinforces-adjuvant-osimertinib-standard-care-patients-stage?cid=DM13797&bid=275994020. Last Updated June 4, 2023. Accessed June 13, 2023.
8. Janssen Staff. Janssen Presents Longer-Term Talquetamab Follow-Up Data Showing Overall Response Rates of More Than 70 Percent in Heavily Pretreated Patients with Multiple Myeloma. Janssen Press Release. https://www.janssen.com/janssen-presents-longer-term-talquetamab-follow-data-showing-overall-response-rates-more-70-percent#_edn1. Last Updated June 4, 2023. Accessed June 13, 2023.
9. Janssen Staff. Janssen Presents First-Ever Results from Dual Bispecific Combination Study Showing 96 Percent Overall Response Rate in Patients with Relapsed or Refractory Multiple Myeloma. Janssen Press Release. https://www.janssen.com/janssen-presents-first-ever-results-dual-bispecific-combination-study-showing-96-percent-overall. Last Updated June 3, 2023. Accessed June 13, 2023
10. Kara Nyberg, PhD. TALAPRO-2: First-Line Talazoparib/Enzalutamide Excels in Patients With BRCA-Mutated mCRPC. ASCO Daily News. https://dailynews.ascopubs.org/do/talapro-2-first-line-talazoparib-enzalutamide-excels-patients-brca--mutated-mcrpc?cid=DM13797&bid=275994020. Lat Updated June 4, 2023. Accessed June 13, 2023.
11. ASCO Staff. ATOM Coalition Seeks to Ensure Equitable Cancer Care in Low- and Middle-Income Countries. ASCO Post News. https://ascopost.com/news/june-2023/atom-coalition-seeks-to-ensure-equitable-cancer-care-in-low-and-middle-income-countries/?utm_source=TAP%2DEN%2D060223&utm_medium=email&utm_term=d959aa38b17f132c7c3a9c8ac701dbbf. Last Updated June 2, 2023. Accessed June 13, 2023.

About the Author

Douglas Braun, PharmD, CSP, RPh, is the senior pharmacy director at the American Oncology Network, LLC in Fort Myers, Florida.