Commentary

Article

October 19, 2023

ESMO 2023: Experts Preview Anticipated Data Spanning Tumor Types

Author(s):

The 2023 ESMO Congress, which is taking place in Madrid, Spain, and will continue to be accessible online via a virtual platform, is gearing up to kick off, and the oncology community is ready to learn more about the latest data across malignancies.

Heather Wakelee, MD

As oncologists, patients, and other stakeholders prepare for invigorating discussions on developments, challenges, and even controversies, OncLive^® spoke with some leading experts in lung cancer, melanoma, genitourinary cancers, and breast cancer to discuss some of the highly anticipated research on established and emerging agents that are being presented during the meeting, and what these updates could mean for clinical practice.

Lung Cancer

Heather Wakelee, MD, professor of medicine (oncology) and medical oncologist at Stanford Medicine
Balazs Halmos, MD, professor in the Department of Oncology and the Department of Medicine, as well as the associate director of Clinical Science at Montefiore Einstein Comprehensive Cancer Center
Ibiayi Dagogo-Jack, MD, instructor of medicine at Harvard Medical School and thoracic oncologist of internal medicine/medical oncology at Massachusetts General Hospital
Apar Kishor Ganti, MD, professor in the Division of Oncology & Hematology at the University of Nebraska Medical Center (UNMC), associate director of clinical research at the UNMC Fred and Pamela Buffett Cancer Center, member of the Respiratory Committee of the Alliance for Clinical Trials in Oncology, chair of the Small Cell Lung Cancer Committee of the National Comprehensive Cancer Network, and VA Clinical Science Research & Development Centralized Data Monitoring Committee

Amivantamab plus lazertinib vs osimertinib as first-line treatment in patients with EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results from MARIPOSA, a phase III, global, randomized, controlled trial (Abstract LBA14)

Apar Kishor Ganti, MD

“The most exciting abstract in my mind is the [one on the] MARIPOSA trial, which is looking at a combination of amivantamab, which is currently approved for EGFR exon 20 insertion mutations, and lazertinib,” Ganti said. “This combination is being compared with the current standard-of-care [SOC] for first-line patients with EGFR-mutated lung cancer, osimertinib. The results of that are exciting because if the combination is shown to be better than osimertinib, then that could very well become the new SOC for [these] patients.”

The open-label, randomized, phase 3 MARIPOSA trial (NCT04487080) enrolled patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring EGFR mutations and randomized them to 1 of 3 arms. In arm A, patients received 1050 mg of intravenous (IV) amivantamab-vmjw (Rybrevant; for those with a bodyweight <80 kg) or 1400 mg of IV amivantamab (for those with a bodyweight ≥ 80 kg) once weekly in cycle 1 with a split dose on days 1 and 2, followed by once every 2 weeks in subsequent cycles, plus 240 mg of oral lazertinib (Leclaza) once per day. In the control group (arm B), patients received 80 mg of oral osimertinib once per day plus a matching lazertinib placebo once per day. In the other experimental group (arm C), patients received 240 mg of lazertinib once per day plus a matching osimertinib placebo once per day.

The doublet was found to significantly improve progression-free survival (PFS) vs osimertinib (Tagrisso) in this population, and the planned interim analysis showed an overall survival (OS) trend favoring amivantamab plus lazertinib.¹Detailed data, including secondary end point findings, will be presented at the meeting.

“[MARIPOSA] is also potentially practice-changing for [patients with] EGFR-mutated NSCLC patients who have progressed on osimertinib,” Wakelee said.

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): Results of the randomized phase III study TROPION-Lung01 (Abstract LBA12)

Balazs Halmos, MD

In the phase 3 TROPION-Lung01 trial (NCT04656652), patients with locally advanced or metastatic NSCLC who received at least 1 prior line of therapy were randomly assigned to receive datopotamab deruxtecan (DS-1062a) at 6.0 mg/kg once every 3 weeks or docetaxel at 75 mg/m² once every 3 weeks. “[TROPION-Lung01 asks,] ‘Can a drug finally beat measly docetaxel?’” Halmos said.

In July 2023, it was announced that the trial met its primary end point in that the TROP2-directed antibody-drug conjugate significantly improved PFS over SOC docetaxel in this population.² OS data were immature. At the time of the interim analysis, an OS trend favoring the datopotamab deruxtecan arm was observed but it did not reach a prespecified threshold for statistical significance.

“[Data on] datopotamab deruxtecan vs docetaxel is of interest as it has been very difficult to beat docetaxel in the second-line [setting] and per the press release, this is positive,” Wakelee noted.

Overall survival in the KEYNOTE-671 study of perioperative pembrolizumab for early-stage non-small-cell lung cancer (NSCLC) (Abstract LBA56)

CheckMate 77T: Phase III study comparing neoadjuvant nivolumab (NIVO) plus chemotherapy (chemo) vs neoadjuvant placebo plus chemo followed by surgery and adjuvant NIVO or placebo for previously untreated, resectable stage II–IIIb NSCLC (Abstract LBA1)

In the phase 3 KEYNOTE-671 trial (NCT03425643), patients with resectable stage II, IIIA, or IIIB (T3-4N2) NSCLC were randomly assigned to receive pembrolizumab (Keytruda) plus chemotherapy prior to surgery, followed by resection and single-agent pembrolizumab in the adjuvant setting (n = 397) vs neoadjuvant placebo plus chemotherapy followed by adjuvant placebo (n = 400).

The addition of pembrolizumab significantly improved OS in this population, meeting the dual primary end point of the trial.3 The median OS was not yet reached (NR; 95% CI, not estimable [NE]-NE) in the investigative arm vs 52.4 months (95% CI, 45.7-NE) in the placebo arm, translating to a 28% reduction in the risk of death (HR, 0.72; 95% CI, 0.56-0.93; P = .0103).^4,5Moreover, the median event-free survival (EFS) was also NR (95% CI, 34.1-NE) with pembrolizumab vs 17 months (95% CI, 13.2-22.0) with placebo (HR, 0.58; 95% CI, 0.46-0.72; P < .0001). These data supported the FDA approval of neoadjuvant/adjuvant pembrolizumab in this population. Full results of the analysis will be presented at the ESMO Congress.³

“KEYNOTE-671…is the study [of] neoadjuvant and adjuvant pembrolizumab in early-stage NSCLC,” Ganti said. “It has shown to have a PFS advantage, but OS results are being presented at ESMO. If there is an OS advantage, that would be the first time that an immunotherapy drug has shown an OS advantage in early-stage NSCLC—so that is very exciting.”

Ibiayi Dagogo-Jack, MD

“Related to thoracic tumors, we have a lot of exciting [abstracts] coming up, particularly in the targeted as well as the neoadjuvant space,” Dagogo-Jack said. “[For example,] we’re going to see updates on KEYNOTE-671 and [the phase 3 CheckMate-77T trial (NCT04025879), which is] looking at the question of whether there is a benefit to post-operative nivolumab [Opdivo] after pre-operative chemotherapy/nivolumab.”

In September 2023, it was announced that neoadjuvant nivolumab paired with platinum-based chemotherapy, followed by surgery and adjuvant single-agent nivolumab significantly improved EFS over neoadjuvant placebo plus chemotherapy followed by surgery and adjuvant placebo in patients with resectable stage IIA to IIIB NSCLC, meeting the primary end point of the trial.⁶ OS assessments are ongoing, and detailed findings will be shared at this year’s meeting.

“CheckMate-77T is particularly interesting, [we want] to see how it compares with CheckMate-816 [NCT02998528] and the additional benefit we may see with the adjuvant nivolumab component after neoadjuvant nivolumab/chemotherapy,” Wakelee noted.

ALINA: Efficacy and safety of adjuvant alectinib versus chemotherapy in patients with early-stage ALK+ non-small cell lung cancer (NSCLC) (Abstract LBA2)

“In the targeted therapy space, we’re going to see [the phase 3] ALINA [trial (NCT03456076)] read out, so this was alectinib vs chemotherapy in patients with ALK-positive lung cancer who have had it resected,” Dagogo Jack said.

“[The] ALINA study [asks,] ‘Should we use targeted therapy in adjuvant setting for ALK-positive patients as well, similar to [what we saw with] EGFR[-positive patients and] ADAURA [NCT02511106]?’” Halmos added.

In September 2023, it was announced that ALINA met its primary end point when adjuvant alectinib (Alecensa) significantly improved disease-free survival over platinum-based chemotherapy in patients with completely resected stage IB to IIIA, ALK-positive NSCLC.⁷ At the time of the prespecified interim analysis, OS data were immature. “It will be exciting to see [more about] adjuvant alectinib and the first ALK adjuvant trial result,” Wakelee noted.

KRYSTAL-7: Efficacy and safety of adagrasib with pembrolizumab in patients with treatment-naïve, advanced non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation (Abstract LBA65)

The phase 2/3 KRYSTAL-7 trial (NCT04613596) is examining the safety and efficacy of adagrasib (Krazati) as a monotherapy and in combination with pembrolizumab in patients with advanced NSCLC whose tumors harbor a KRAS G12C mutation. Earlier data from the KRYSTAL-1 (NCT03785249) and KRYSTAL-7 phase 2 cohorts showed that concurrent adagrasib and pembrolizumab had preliminary activity when given in the first-line setting to this patient population, irrespective of PD-L1 status.⁸

“I am interested in KRYSTAL-7, [which is] looking at adagrasib (Krazati) and pembrolizumab, as there have been a lot of challenges with combining TKIs and immuno-oncology [IO] historically, and both adagrasib and IO are active in KRAS-mutant NSCLC,” Wakelee said.

A phase III, randomized study of atezolizumab plus bevacizumab and chemotherapy in patients with EGFR or ALK mutated in non-small cell lung cancer (ATTLAS, KCSG-LU19-04) (Abstract LBA67)

"I am interested in [the phase 3] ATTLAS [trial (NCT03991403)], as we have many questions still about how to bring IO therapy to patients with EGFR mutations," Wakelee said.

Melanoma

Jeffrey S. Weber, MD, PhD, deputy director of Perlmutter Cancer Center and co-director of Melanoma Research Program at NYU Langone Health

Unraveling relatlimab (RELA)-specific biology using biomarker analyses in patients with advanced melanoma treated with nivolumab (NIVO)+RELA or NIVO alone in RELATIVITY-047 (Abstract LBA51)

Jeffrey S. Weber, MD, PhD

“It appears that a lot of the [abstracts] that are being presented [at ESMO] are follow-ups on prior treatments. I’m not aware that there’s going to be any really, really new [melanoma] data being presented but I would look forward to the follow-up on the PD-1/LAG-3 trials that have been conducted in metastatic disease; I think that’s very useful,” Weber said. “We’ll have a follow-up on the RELATIVITY-047 study [NCT03470922], which was the nivolumab/LAG-3 vs nivolumab.”

In March 2022, the FDA approved the fixed-dose combination of relatlimab plus nivolumab (Opdualag) for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma.⁹ The decision was supported by findings from RELATIVITY-047, which had demonstrated that the doublet (n = 355) improved median PFS over nivolumab monotherapy (n = 359) in this population, at 10.1 months (95% CI, 6.4-15.7) vs 4.6 months (95% CI, 3.4-5.6), respectively. Two-year follow-up data continued to show an improvement in PFS with relatlimab/nivolumab vs nivolumab alone (HR, 0.81; 95% CI, 0.67-0.97).¹⁰ Moreover, the median OS was NR with the doublet vs 33.2 months (95% CI, 25.2-45.8) with the monotherapy (HR, 0.82; 95% CI, 0.67-1.02).

mRNA-4157 (V940) individualized neoantigen therapy + pembrolizumab vs pembrolizumab in high-risk resected melanoma: Clinical efficacy and correlates of response (Abstract LBA49)

“I’ll be presenting more data on KEYNOTE-942, which is the [trial evaluating] a neoantigen vaccine [plus] pembrolizumab vs pembrolizumab,” Weber added.

In the phase 2 KEYNOTE-942 trial (NCT03897881), the combination of mRNA-4157 (V940) and pembrolizumab was compared with single-agent pembrolizumab in patients with resected melanoma at high risk of recurrence. At a median follow-up of 23 months in the combination arm and 24 months in the monotherapy arm, the 18-month distant metastasis-free survival (DMFS) rates were 91.8% and 76.8%, respectively (HR, 0.347; 95% CI, 0.145-0.828; P = .0063).¹¹

“So, we’ll see a lot of good follow-up [data]. I suspect next year, if some of the current phase 3 studies mature, probably at ASCO or maybe ESMO, we’ll hear more about [those],” Weber added.

Genitourinary Cancers

Guru P. Sonpavde, MD, medical director of Genitourinary Oncology, assistant director of the Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute

EV-302/KEYNOTE-A39: Open-label, randomized phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (Chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC) (Abstract LBA6)

In April 2023, the FDA granted accelerated approval to enfortumab vedotin-ejfv (Padcev) plus pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.¹²The decision was based on data from the combined dose-escalation/cohort A and cohort K of the phase 1/2 EV-103/KEYNOTE-869 study (NCT03288545). The phase 3 KEYNOTE-A39-EV-302 trial (NCT04223856) serves as the confirmatory trial.

In September 2023, it was announced that the trial met its co-primary end points when the combination improved OS and PFS over chemotherapy in previously untreated patients with locally advanced or metastatic urothelial carcinoma who were not candidates for cisplatin- or carboplatin-containing chemotherapy.¹³At the time of the interim analysis, the OS crossed the prespecified efficacy boundary.

Guru P. Sonpavde, MD

“Enfortumab vedotin plus pembrolizumab significantly improved outcomes in patients with previously untreated locally advanced/metastatic urothelial carcinoma, nearly doubling the median PFS and OS vs chemotherapy,” Sonpavde said. “The safety profile was generally manageable with no new safety signals. These results support enfortumab vedotin plus pembrolizumab as a new SOC for first-line locally advanced/metastatic urothelial carcinoma.”

Nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: Results from the phase III CheckMate 901 trial (Abstract LBA7)

The randomized, open-label, phase 3 CheckMate-901 trial (NCT03036098) evaluated nivolumab plus ipilimumab (Yervoy) in the primary study, and nivolumab plus cisplatin-based chemotherapy in the sub-study, compared with chemotherapy alone in previously untreated, cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma.

In July 2023, it was announced that frontline nivolumab plus cisplatin-based chemotherapy, followed by single-agent nivolumab, significantly improved PFS and OS vs standard cisplatin-based chemotherapy regimens alone in this population, meeting the trial’s dual primary end points.¹⁴

“Nivolumab plus gemcitabine/cisplatin is the first frontline concurrent checkpoint inhibitor plus chemotherapy combination to improve OS in this setting,” Sonpavde said. “These results support nivolumab plus cisplatin-based chemotherapy as a new SOC for patients with metastatic urothelial carcinoma.” Detailed findings from the trial will be shared during the meeting.

Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): Randomized open-label phase III LITESPARK-005 study (Abstract LBA88)

The phase 3 LITESPARK-005 trial (NCT04195750) met its co-primary end point when treatment with belzutifan (Welireg) was found to significantly improve PFS vs everolimus (Afinitor) in patients with advanced renal cell carcinoma (RCC) that had progressed on PD-1/PD-L1 inhibitors and VEGF inhibitors, in sequence or in combination.¹⁵ Belzutifan also improved objective response rate (ORR) compared with everolimus. At the time of the prespecified interim analysis, a trend toward OS was also observed with belzutifan.

In September 2023, the FDA granted priority review to a supplemental new drug application seeking the approval of belzutifan in previously treated patients with advanced RCC after immune checkpoint inhibitors and antiangiogenic therapies.¹⁶ The application is based on findings from the trial, and the regulatory agency is slated to decide by January 17, 2024.

“Belzutifan, a HIF-2α inhibitor, was associated with a statistically significant improvement in PFS and ORR vs everolimus for pts with advanced clear cell RCC after immune checkpoint and antiangiogenic therapies,” Sonpavde said. “The safety profile of belzutifan was consistent with prior reports with no new safety signals.”

Enzalutamide and 177Lu-PSMA-617 in poor-risk, metastatic, castration-resistant prostate cancer (mCRPC): A randomised, phase II trial: ENZA-p (ANZUP 1901) (Abstract LBA84)

The open-label, randomized, 2-arm, multicenter, phase 2 ENZA-p (ANZUP 1901) trial (NCT04419402) randomly assigned patients with metastatic castration-resistant prostate cancer (mCRPC) at high-risk of early progression on enzalutamide (Erleada) alone in a 1:1 fashion to enzalutamide at a daily dose of 160 mg or enzalutamide at a daily dose of 160 mg plus ¹⁷⁷Lu-PSMA-617 at 7.5 GBq on days 15 and 57.¹⁷

“Data support enhanced anticancer activity with the use of adaptive-dosed LuPSMA together with enzalutamide as first-line treatment in mCPRC,” Sonpavde noted.

Phase III trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (PSMAfore) (Abstract LBA13)

The phase 3 PSMAfore trial (NCT04689828) evaluated the safety and efficacy of the prostate-specific membrane antigen (PSMA)–targeted radioligand therapy lutetium vipivotide tetraxetan (Pluvicto) vs a change in androgen-receptor pathway inhibitor (ARPI) therapy in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) with prior exposure to an ARPI. The trial met its primary end point of radiographic PFS (rPFS) in December 2022.¹⁸

“¹⁷⁷Lu-PSMA-617 prolonged rPFS vs ARPI change in taxane-naïve patients with PSMA-positive mCRPC following 1 prior ARPI, with a favorable safety profile,” Sonpavde noted.

Phase III THOR study: Results of erdafitinib (erda) vs pembrolizumab (pembro) in pretreated patients (pts) with advanced or metastatic urothelial cancer (muc) with select fibroblast growth factor receptor alterations (FGFRalt) (Abstract 2359O)

"Erdafitinib [Balversa] and pembrolizumab had similar OS in this anti–PD-(L)1 naïve, FGFR-altered metastatic urothelial carcinoma population, with erdafitinib showing a numerically longer PFS and numerically higher ORR rate," Sonpavde said. "Toxicities were manageable with dose modifications."

Interim results from a phase I study of AMG 509 (xaluritamig), a STEAP1 x CD3 XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC) (Abstract 1765O)

"Xaluritamig was tolerable, with low-grade cytokine release syndrome, occurring primarily cycle 1, with encouraging preliminary efficacy in heavily pretreated patients with mCRPC," Sonpavde noted.

Breast Cancer

Heather McArthur, MD

Heather McArthur, MD, associate professor in the Department of Internal Medicine and clinical director of the Breast Cancer Program at Simmons Cancer Center, and Komen Distinguished Chair in Clinical Breast Cancer Research, at UT Southwestern Medical Center

Pembrolizumab or placebo plus chemotherapy followed by pembrolizumab or placebo for early-stage TNBC: Updated EFS results from the phase III KEYNOTE-522 study (Abstract LBA18)

A randomized, double-blind trial of nivolumab (NIVO) vs placebo (PBO) with neoadjuvant chemotherapy (NACT) followed by adjuvant endocrine therapy (ET) ± NIVO in patients (pts) with high-risk, ER+ HER2− primary breast cancer (BC) (Abstract LBA20)

KEYNOTE-756: Phase III study of neoadjuvant pembrolizumab (pembro) or placebo (pbo) + chemotherapy (chemo), followed by adjuvant pembro or pbo + endocrine therapy (ET) for early-stage high-risk ER+/HER2– breast cancer (Abstract LBA21)

In the phase 3 KEYNOTE-522 trial (NCT03036488), patients with treatment-naïve stage II or III triple-negative breast cancer were randomly assigned 2:1 to receive neoadjuvant therapy with 4 cycles of pembrolizumab at 200 mg (n = 784) or placebo (n = 390) every 3 weeks in combination with paclitaxel and carboplatin, followed by 4 cycles of pembrolizumab or placebo paired with doxorubicin and cyclophosphamide or epirubicin and cyclophosphamide.¹⁹ After undergoing definitive surgery, patients were administered adjuvant pembrolizumab or placebo every 3 weeks for up to 9 treatment cycles.

Primary data showed that the estimated EFS rate at 36 months in the pembrolizumab arm was 84.5% (95% CI, 81.7%-86.9%) vs 76.8% (95% CI, 72.2%-80.7%) in the placebo arm (HR, 0.63; 95% CI, 0.48-0.82; P < .001). Updated EFS data will be shared at the meeting.

The randomized, double-blind, phase 3 KEYNOTE-756 trial (NCT03725059) met one of its dual primary end points when neoadjuvant pembrolizumab plus chemotherapy improved pathologic complete response (pCR) rate vs placebo plus chemotherapy in patients with high-risk, early-stage, estrogen receptor–positive, HER2-negative breast cancer. Detailed data will be released at the meeting.

The phase 3 CheckMate-7FL (NCT04109066) is assessing nivolumab compared with placebo in combination with neoadjuvant chemotherapy and adjuvant endocrine therapy in patients with high-risk, estrogen receptor–positive, HER2-negative primary breast cancer.²¹ Primary end points are pCR and EFS.

“I am most excited about the KEYNOTE-522 EFS update, and the 2 neoadjuvant immune therapy studies (CheckMate-7FL and KEYNOTE-756),” McArther said. “The latter 2 could be practice changing for hormone receptor–positive disease!”

References

Landmark phase 3 MARIPOSA study meets primary endpoint resulting in statistically significant and clinically meaningful improvement in PFS for Rybrevant (amivantamab-vmjw) plus lazertinib versus osimertinib in patients with EGFR-mutated NSCLC. News release. Janssen. September 28, 2023. Accessed October 19, 2023. https://www.janssen.com/landmark-phase-3-mariposa-study-meets-primary-endpoint-resulting-statistically-significant
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