As the 2024 edition of the American Society of Clinical Oncology (ASCO) Annual Meeting drew to a close, clinicians were left to digest practice-changing presentations, sparking excitement among those who attended the meeting in Chicago, Illinois.

Bradley McGregor, MD

“In the field of renal cell carcinoma [RCC], this ASCO has been important because we’re seeing more biomarker sessions,” Laurence Albiges, MD, PhD, of Gustave Roussy in Villejuif, France, said in an interview with OncologyLive. Bradley McGregor, MD, of Dana-Farber Cancer Institute in Boston, Massachusetts, added, “We’re seeing incremental steps trying to take the data we have and find signals. The story of KIM-1 in the adjuvant space for RCC is intriguing—might that be a biomarker we can [use to] help identify which patients need to undergo adjuvant therapy for RCC?”

ASCO 2023-2024 president, Lynn M. Schuchter, MD, also emphasized the importance of building a bridge between the academic and community setting, tying into her theme of the meeting: “The Art and Science of Cancer Care: From Comfort to Cure.”

Lynn M. Schuchter, MD

“Across the US and globally, the lines are [becoming] much more blurred between academic medical oncologists and the community setting. Our patients are in the community, want access to clinical trials, [and] more community oncologists recognize the need for specialization,” Schuchter said.

Through our live coverage, we conducted more than 100 exclusive interviews with key opinion leaders, and our OncLive News Network^®: On Location interviews hosted by Chandler Park, MD, FACP, of Norton Cancer Institute, and Yan Leyfman, MD, of Memorial Sloan Kettering Cancer Center, captured all aspects of this year’s ASCO meeting. See top-line coverage below of nearly 20 exciting abstracts and visit onclive.com/conference/asco for full, comprehensive coverage of the data.

For a full list of abstracts, visit: bit.ly/3xpb8jC.

Breast Cancer

V. K. Gadi, MD, PhD

University of Illinois Cancer Center, UI Health

V. K. Gadi, MD, PhD

"Of the] top 3 [abstracts presented at ASCO], DESTINY-Breast06 is up there. It’s practice changing, and anything that changes practice in hormone receptor–positive breast cancer—the most common breast cancer—is probably first place.”

Abstract LBA1000

Findings from the phase 3 DESTINY-Breast06 trial (NCT04494425) revealed that treatment with fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) vs investigator’s choice of chemotherapy in pretreated patients with hormone receptor–positive, HER2-low metastatic breast cancer.

The median PFS among patients with HER2-low disease who received T-DXd (n = 359) was 13.2 months vs 8.1 months for those given chemotherapy (n = 354; HR, 0.62; 95% CI, 0.51-0.74; P < .0001) per blinded independent central review (BICR). In the intention-to-treat (ITT) population comprised of patients with HER2-low and -ultralow disease, the median PFS was 13.2 months with T-DXd (n = 436) vs 8.1 months with chemotherapy (n = 430; HR, 0.63; 95% CI, 0.53-0.75; P < .0001). At approximately 40% maturity, the 12-month overall survival (OS) data showed an OS rate of 87.6% in the T-DXd arm vs 81.7% in the chemotherapy arm among patients with HER2-low disease and 87.0% vs 81.1%, respectively, in the ITT population.

Kevin Kalinsky, MD, MS

Winship Cancer Institute of Emory University

Kevin Kalinsky, MD, MS

"This study’s data demonstrated that this combination is a strategy for patients where [appropriate]; abemaciclib is widely available with a toxicity profile that we know and understand. Also, 30% of patients in this study were biomarker negative—they didn’t have an ESR1 mutation or a PI3K pathway alteration—and for those patients this offers a targeted therapy option post CDK4/6 inhibition. Regardless of the presence or absence of an ESR1 mutation or PI3K pathway alteration, [patients experienced] benefit with fulvestrant and abemaciclib.”

Abstract LBA1001

The phase 3 postMONARCH trial (NCT05169567) was the first phase 3, randomized, placebo-controlled study to demonstrate the benefit of continued CDK4/6 inhibition beyond progression on a CDK4/6 inhibitor. Study findings showed that the addition of abemaciclib (Verzenio) to fulvestrant (Faslodex) led to a significant improvement in PFS vs fulvestrant alone in patients with hormone receptor–positive, HER2-negative advanced breast cancer who had disease progression on a CDK4/6 inhibitor and endocrine therapy.

Data from the primary analysis indicated that treatment with the doublet (n = 182) led to a median investigator-assessed PFS of 6.0 months (95% CI, 5.6-8.6) vs 5.3 months (95% CI, 3.7-5.6) with fulvestrant alone (n = 186), translating to a 27% reduction in the risk of disease progression or death (HR, 0.73; 95% CI, 0.57-0.95; nominal P = .02). The 6-month PFS rates in the respective arms were 50% and 37%.

Dejan Juric, MD

Massachusetts General Hospital

Dejan Juric, MD

"[For] PFS2, time from randomization to experimental vs placebo therapy and then progression on the second therapy, it was interesting to see [that] the difference between the 2 arms widens—it was 24.0 months vs 15.1 months, respectively. Now the Δ is 8.9 months, meaning if you’re treating patients with a potentially better therapy in the first line that keeps giving [benefit, then] the second line [will] look better as well in patients who receive triplet vs fulvestrant plus palbociclib plus placebo. That was an important piece of information [from INAVO120].”

Abstract 1003

Based on data from the phase 3 INAVO120 trial (NCT04191499), on May 28, 2024, the FDA granted priority review to the new dr

ug application seeking the approval of inavolisib (GDC-0077) in combination with palbociclib (Ibrance) and fulvestrant for the treatment of adult patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer harboring PIK3CA mutations, following recurrence on or within 12 months of completing adjuvant endocrine therapy. The target action data for the FDA decision is November 27, 2024.

INAVO120 met its primary end point as patients treated with inavolisib plus palbociclib and fulvestrant (n = 161) experienced a statistically significant and clinically meaningful improvement in PFS compared with placebo plus palbociclib and fulvestrant (n = 164; HR, 0.43; 95% CI, 0.32-0.59; P < .0001). Additional efficacy data presented at the 2024 ASCO Annual Meeting revealed that at a median follow-up of 21.3 months, the median time from random assignment to end or discontinuation of next-line treatment or death from any cause was 24.0 months (95% CI, 18.6-not evaluable [NE]) vs 15.1 months (95% CI, 13.5-22.3), respectively (stratified HR, 0.54; 95% CI, 0.38-0.77).

Gynecology

Don S. Dizon, MD

Lifespan Cancer Institute

Don S. Dizon, MD

"The interesting finding is that [treatment with] the combination of nivolumab and ipilimumab [elicited] a higher response rate of 33%, including 5 patients who had a CR, which is unheard of in [those with] clear cell carcinoma who have received prior chemotherapy and have advanced or metastatic disease. Importantly, patients who responded to the combination had a durable response; we had patients staying on study as they approached the 2-year mark, and even today patients are continuing treatment.”

Abstract LBA5500

Combination treatment with nivolumab (Opdivo) plus ipilimumab (Yervoy) bested nivolumab monotherapy, according to data from the final analysis of the phase 2 BrUOG 354 trial (NCT03355976), which demonstrated that patients with recurrent, advanced, or metastatic ovarian or other extra-RCC carcinomas experienced improved outcomes with the combination vs monotherapy.

Findings showed that 16.7% of patients treated with nivolumab plus ipilimumab (n = 30) achieved a complete response (CR), whereas no patients treated with nivolumab alone (n = 14) experienced a CR; partial response rates were 16.7% vs 14.3%, respectively. Additionally, the median PFS was 5.6 months (95% CI, 1.6-29.2) in the doublet arm compared with 2.2 months (95% CI, 1.2-3.4) in the monotherapy arm, and the median OS was 24.7 months (95% CI, 5.9-not reached [NR]) vs 17.3 months (95% CI, 2.1-42.7), respectively.

Bhavana Pothuri, MD

NYU Langone Health

Bhavana Pothuri, MD

"[This] very interesting phase 3 trial [was examining] lymph node assessment in patients undergoing interval cytoreduction. That is practice-changing [data], because we don’t need to incorporate lymph node dissection in normally appearing lymph nodes when patients undergo interval cytoreduction [therapy] after neoadjuvant chemotherapy in ovarian cancer.”

Abstract LBA5505

Data from the phase 3 CARACO trial (NCT01218490) revealed that adding retroperitoneal lymphadenectomy to cytoreductive surgery in primary surgery or interval surgery following neoadjuvant chemotherapy does not improve PFS or OS in patients with advanced ovarian cancer and no suspicious nodes.

Regarding the primary end point of PFS, patients who did not receive retroperitoneal lymphadenectomy (n = 193) experienced a median PFS of 14.8 months compared with 18.6 months for those who did (HR, 0.96; 95% CI, 0.77-1.20; P = .712). The median OS was 48.9 months compared with 58.8 months, respectively (HR, 0.92; 95% CI, 0.72-1.17; P = .489).

Gastrointestinal Cancer

Vivek Subbiah, MD

Sarah Cannon Research Institute

Vivek Subbiah, MD

"[This phase 2] study with dostarlimab checkpoint therapy was originally presented at ASCO and published in The New England Journal of Medicine [in 2022] and showed 14 of 14 patients achieved CRs in the early-line setting. [This] data set of a larger number of patients demonstrates and validates that in a biomarker-driven population of patients with rectal cancer in an early setting, a lot of patients can achieve CRs. In oncology, studies [such as this] show that [if] we treat patients with potent drugs earlier, we can improve outcomes.”

Abstract LBA3512

All 42 patients with locally advanced mismatch repair–deficient (dMMR) rectal cancer who completed treatment with dostarlimab-gxly (Jemperli) in a phase 2 study (NCT04165772) achieved a clinical CR, and responses were durable at a median follow-up of 17.9 months (range, 0.3-50.5). Following treatment with the PD-1 inhibitor, 24 patients experienced a sustained clinical CR at a median follow-up of 26.3 months (range, 12.4-50.5). Investigators also noted that no patients in the trial have required chemotherapy, radiation therapy, or surgery.

Initial results of the trial were presented at the 2022 ASCO Annual Meeting and showed a 100% clinical CR rate in 14 patients with stage II or III dMMR rectal cancer who received treatment with dostarlimab. The confirmatory, global, single-arm, phase 2 AZUR-1 trial (NCT05723562) is also ongoing and anticipates an estimated enrollment of 150 patients.

Chiara Cremolini, MD, PhD

University of Pisa

Chiara Cremolini, MD, PhD

"The most relevant news in the field of colorectal cancer [CRC] is the TRANSMET trial…that shows a very significant advantage in the liver transplantation [plus chemotherapy arm vs chemotherapy alone arm] in terms of 5-year OS, which was the primary end point of the study. Even more [benefit was seen] in the per-protocol population [with a HR of 0.16] when compared with the ITT population where there was a HR of 0.37. But a clear benefit [was seen] from this procedure that has never been considered in the treatment armamentarium for patients with metastatic CRC. These data are big news and something that we will need to include in our multidisciplinary evaluations in front of patients with metastatic CRC with liver-limited disease.”

Abstract 3500

The addition of liver transplantation to chemotherapy significantly improved OS and PFS vs chemotherapy alone in patients with unresectable colorectal liver metastases, according to data from the TRANSMET trial (NCT02597348). Patients who received liver transplantation and chemotherapy (n = 36) experienced a 5-year OS rate of 73% compared with 9% for patients who received chemotherapy alone (n = 38) in the per-protocol population of the trial (HR, 0.16; 95% CI, 0.07-0.33; log-rank P < .0001).

At a median follow-up of 59 months, the 5-year OS rate in the ITT population was 57% in the transplantation arm (n = 47) vs 13% in the chemotherapy alone arm (n = 47; HR, 0.37; 95% CI, 0.21-0.65; P = .0003). The 5-year PFS rates were 20% compared with 0%, respectively (HR, 0.34; 95% CI, 0.20-0.57; log-rank P < .0001).

Karyn A. Goodman, MD, MS

The Tisch Cancer Institute, Mount Sinai

Karyn A. Goodman, MD, MS

"As a gastrointestinal radiation oncologist, one of the most important studies was the ESOPEC trial in esophageal cancer. The study showed that there was an improvement in OS for the use of FLOT vs the CROSS regimen. Although FLOT is probably going to be a more commonly used regimen in the US, it’s a very difficult regimen for patients to tolerate, so the CROSS regimen is still a viable option. Also, this study didn’t evaluate the use of CROSS followed by surgery followed by adjuvant nivolumab, which we’ve seen has significantly improved disease-free survival [DFS] for patients who have undergone CROSS followed by surgery. We still have an option with CROSS followed by surgery followed by nivolumab.”

Abstract LBA1

At a median follow-up of 55 months, perioperative chemotherapy with docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT protocol) improved OS compared with neoadjuvant chemoradiation (CROSS protocol) for patients with resectable esophageal cancer. Data from the phase 3 ESOPEC trial (NCT02509286) showed that patients in the ITT population who received the FLOT protocol (n = 221) achieved a median OS of 66 months (95% CI, 36-NE) compared with 37 months (95% CI, 28-43) among those who were treated with the CROSS protocol (n = 217; HR, 0.70; 95% CI, 0.53-0.92; P = .012).

Additionally, the 3-year OS rates were 57.4% vs 50.7%, respectively, and the 5-year respective OS rates were 50.6% vs 38.7%.

Richard Kim, MD

Moffitt Cancer Center

Richard Kim, MD

"Data from the CheckMate 9DW study in HCC could be practice changing using the combination of nivolumab/ipilimumab in the first-line setting against a tyrosine kinase inhibitor [TKI]. It is very important because the first-line setting of HCC is very crowded right now. There are data with atezolizumab [Tecentriq] plus bevacizumab [Avastin] and with durvalumab [Imfinzi] plus tremelimumab [Imjudo], and those 2 regimens are currently approved. We also heard most recently from the phase 3 CARES-310 study [NCT03764293] that you can give a TKI and [an] immuno-oncology agent in this setting, and [there is an] OS benefit. That regimen with camrelizumab plus rivoceranib is not currently approved yet but will hopefully receive approval in the future. With [these] data—now that nivolumab/ipilimumab met it’s OS end point—it [could] be a fourth combination that may get approved in the first-line setting, giving us more options. Then, as clinicians, we have to decide which regimen to choose.”

Abstract LBA4008

The combination of nivolumab and ipilimumab was superior to both lenvatinib (Lenvima) and sorafenib (Nexavar) in unresectable hepatocellular carcinoma (HCC), demonstrating a statistically significant OS benefit and higher response rates. Findings from the phase 3 CheckMate 9DW trial (NCT04039607) showed that the median OS among patients treated with nivolumab plus ipilimumab (n = 335) was 23.7 months (95% CI, 18.8-29.4) compared with 20.6 months (95% CI, 17.5-22.5) with lenvatinib/sorafenib (n = 333; HR, 0.79; 95% CI, 0.65-0.96; P = .018).

Further, the overall response rate (ORR) was 36% (95% CI, 31%-42%) in the immunotherapy arm with a median duration of response (DOR) of 30.4 months (95% CI, 21.1-NE) vs 13% (95% CI, 10%-17%) in the lenvatinib/sorafenib arm with a median DOR of 12.9 months (95% CI, 10.2-31.2).

Genitourinary Cancer

Roger Li, MD

Moffitt Cancer Center

Roger Li, MD

"The CORE-001 study has certainly made a big impact; it’s brought this option for patients who [may be] fearful of developing progressive disease while on treatment. We have a very viable and tolerable drug combination going forward.”

Abstract 4601

The long-term durable responses experienced by patients with BCG–unresponsive, high-risk non–muscle-invasive bladder cancer with carcinoma in situ who received treatment with cretostimogene grenadenorepvec (CG0070) plus pembrolizumab (Keytruda) suggest that the doublet may be a novel bladder-sparing strategy, according to investigators of the phase 2 CORE-001 trial (NCT04387461).

In CORE-001, 82.9% of patients who received the conditionally replicating, intravesically delivered adenovirus plus pembrolizumab (n = 335) experienced a CR at any time. Additionally, the 12-month CR rate was 57.1% (95% CI, 39.5%-73.2%) and the 24-month CR rate was 54.3% (95% CI, 36.9%-70.8%). The PFS rate was 100%; no patients experienced disease progression to muscle-invasive bladder cancer or metastatic urothelial carcinoma.

David A. Braun, MD, PhD

Yale Cancer Center

David A. Braun, MD, PhD

"Although this study was negative, afterward investigators looked at subpopulations of patients who might benefit from therapy [with atezolizumab]. Vincent Wenxin Xu, MD, has done remarkable work on the circulating protein KIM-1 and has shown that it is predictive of diagnosis of kidney cancer vs a benign entity, [and that] it’s associated with worse outcomes after resection of a tumor in the metastatic setting. [When investigators then] looked at this in the setting of IMmotion010, results were markedly different based on KIM-1 levels. In the KIM-1–low setting there was no benefit, it mimicked the overall trial with no benefit whatsoever for atezolizumab. But patients with high KIM-1 levels after surgery experienced a significant and clinically meaningful benefit [with] atezolizumab treatment. That’s not going to change atezolizumab’s [use] specifically, it’s not going to make that a viable therapy today, but it’s proof of concept that we’re starting to develop biomarkers to be able to rationally select patients. Because right now, with adjuvant therapy, we undertreat some patients and overtreat others. If we have a rational way to select who’s going to benefit the most from these therapies, we’re going to do our patients a great service, so this study is a very important contribution to the literature.”

Abstract 4506

An exploratory analysis of data from the phase 3 IMmotion010 trial (NCT03024996) found that high postnephrectomy KIM-1 serum levels showed potential as a circulating protein biomarker for minimal residual disease and disease recurrence in patients with RCC in the adjuvant setting. Atezolizumab also improved DFS vs placebo in patients with high-baseline KIM-1 serum levels, and a baseline KIM-1 level of 86 pg/mL was identified to define high vs low expression.

KIM-1–high status was associated with worse DFS outcomes, as patients with KIM-1–high disease (n = 300) experienced a median DFS of 35.88 months compared with 57.23 months for those with KIM-1–low disease (n = 452; HR, 1.75; 95% CI, 1.40-2.17). Further, in the KIM-1–high subgroup, DFS outcomes were improved for patients who received atezolizumab (n = 151) vs placebo; the median DFS was NE vs 21.16 months (n = 149; HR, 0.72; 95% CI, 0.52-0.99), respectively.

Lung Cancer

Missak Haigentz Jr, MD

RWJBarnabas Health

Missak Haigentz Jr, MD

"The impressive results of ADRIATIC demonstrated that [there was a] reduction in risk of mortality by 27%. There were 10% gains in 2- and 3-year OS that coupled with PFS. [Although] more than 50% of patients had disease progression at 2 years, this is only the beginning of being able to study novel and combination immunotherapies. ADRIATIC has not read out its combination arm of durvalumab plus tremelimumab, and there are a number of other investigational studies that are seeking to improve on [these data].”

Abstract LBA5

The administration of durvalumab as consolidation treatment following concurrent chemoradiotherapy significantly improved OS and PFS vs placebo in patients with limited-stage small cell lung cancer (LS-SCLC). This represents a critical finding as no major advancements have occurred with systemic treatment for LS-SCLC in decades, according to investigators of the phase 3 ADRIATIC study (NCT03703297).

Data from the first planned interim analysis at a median follow-up of 37.2 months (range, 0.1-60.9) in censored patients demonstrated that the median OS was 55.9 months (95% CI, 37.3-NE) for patients treated with the immunotherapy (n = 264)vs 33.4 months (95% CI, 25.5-39.9) with placebo (n = 266; HR, 0.73; 95% CI, 0.57-0.93; P = .0104).

John V. Heymach, MD, PhD

The University of Texas MD Anderson Cancer Center

John V. Heymach, MD, PhD

"In the LAURA study for patients with [EGFR-mutant] stage III NSCLC after standard chemoradiotherapy [treatment], patients received osimertinib and the results were spectacular. [Osimertinib] dramatically prolonged the likelihood of being progression free, reducing the likelihood of recurrence. The HR corresponded to an 84% reduction in the likelihood of the cancer coming back in the rate of progression. That’s a spectacular finding—every bit as spectacular as the earlier phase 3 ADAURA study [NCT02511106]—so that’s immediately practice changing.”

Abstract LBA4

Data from the phase 3 LAURA trial (NCT03521154) revealed that treatment with osimertinib (Tagrisso) following definitive chemoradiotherapy led to a statistically significant and clinically meaningful improvement in PFS vs placebo in patients with locally advanced, unresectable, stage III non–small cell lung cancer (NSCLC) harboring an EGFR mutation.

Patients treated with osimertinib (n = 143) experienced a median PFS of 39.1 months (95% CI, 31.5-not calculable) vs 5.6 months (95% CI, 3.7-7.4) for patients who received placebo (n = 73; HR, 0.16; 95% CI, 0.10-0.24; P < .001) by BICR. Additionally, the 12- and 24-month PFS rates in the osimertinib arm were 74% and 65%, respectively. Those respective rates were 22% and 13% in the placebo arm.

Sundar Jagannath, MBBS

The Tisch Cancer Institute, Mount Sinai

Sundar Jagannath, MBBS

"The biggest news [from ASCO came from] the plenary presentation on the outcomes of patients with lung cancer with ALK-positive mutations. Before, lung cancer was almost like a death sentence and now, with [lorlatinib treatment], patients are living 5 years and longer. There was a lead article in The New York Times talking about a patient who [was diagnosed with] lung cancer at a young age and he was able to get on this antibody and subsequently has gotten married, had children, and gotten a new job. He can look forward to living a full life as a father and young man. That is dramatic news that is coming out of this ASCO meeting.”

Abstract LBA8503

Five-year follow-up data from the phase 3 CROWN trial (NCT03052608) showed that patients with advanced ALK-positive disease who received lorlatinib (Lorbrena) in the frontline setting vs crizotinib (Xalkori) experienced the longest PFS ever reported in advanced NSCLC; treatment with lorlatinib reduced the risk of disease progression or death by 81% vs crizotinib.

The median PFS was NR (95% CI, 64.3-NR) in the lorlatinib arm (n = 149) compared with 9.1 months (95% CI, 7.4-10.9) in the crizotinib arm (n = 147; HR, 0.19; 95% CI, 0.13-0.27). The 5-year PFS rates were 60% vs 8%, respectively, at a median follow-up of 60.2 months. Additionally, OS follow-up is ongoing, as the required number of OS events for a protocol-specified second interim analysis have not been reached. Furthermore, patients who had brain metastases at baseline achieved a median PFS of NR (95% CI, 32.9-NR) when treated with lorlatinib (n = 35) vs 6.0 months (95% CI, 3.7-7.6) with crizotinib (n = 38), for a 92% reduction in the risk of disease progression or death (HR, 0.08; 95% CI, 0.04-0.19).

Hematology

Michael W. Deininger, MD, PHD

Versiti Blood Research Institute

Michael W. Deininger, MD, PHD

"The data from the asciminib vs alternative TKI phase 3 [ASC4FIRST] study are very exciting. Significantly higher rates of MMR [were seen] in favor of the asciminib arm vs imatinib. [Treatment with asciminib also] demonstrated better tolerability compared with both imatinib and second-generation TKIs, so this is a very interesting study. Longer follow-up is required, but it is a significant advance. I have to see how drug prices are going to play out in this setting—there are questions around that—but looking at the efficacy data and the tolerability data in isolation are impressive results.”

Abstract LBA6500

The BCR::ABL1 inhibitor asciminib (Scemblix) induced statistically significant and clinically meaningful major molecular response (MMR) benefits vs standard-of-care (SOC) TKIs in patients with newly diagnosed, Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

Data from the primary analysis of the phase 3 ASC4FIRST trial (NCT04971226) indicated that patients who received asciminib (n = 201) achieved a 48-week MMR rate of 67.7% compared with 49.0% among patients who were treated with an investigator-selected TKI (n = 204); this represented an 18.9% (95% CI, 9.6%-28.2%; P < .001) improvement. Further, in the imatinib (Gleevec) stratum of both arms, the 48-week MMR rates were 69.3% in the analysis arm (n = 101) vs 40.2% in the TKI arm (n = 102), for an improvement of 29.6% (95% CI, 16.9%-42.2%; P < .001).

María-Victoria Mateos, MD, PhD

University Hospital of Salamanca

María-Victoria Mateos, MD, PhD

"There are 3 key presentations at ASCO that will be changing practice [in hematology]. Two presentations will be based on [data with] belantamab mafodotin in combination with bortezomib and dexamethasone in the DREAMM 7 study [NCT04246047] and in combination with pomalidomide and dexamethasone in the DREAMM 8 study. These 2 clinical studies will put into context how belantamab mafodotin plus either bortezomib and dexamethasone or pomalidomide and dexamethasone are going to be a new SOC for patients with relapsed/refractory myeloma after at least 1 prior line of therapy.”

Abstract LBA105

Data from the phase 3 DREAMM 8 trial (NCT04484623) revealed that the addition of belantamab mafodotin-blmf (Blenrep) to pomalidomide (Pomalyst) and dexamethasone (BPd) generated a statistically significant and clinically meaningful improvement in PFS vs bortezomib (Velcade) plus pomalidomide and dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma.

In DREAMM 8, the median PFS was NR (95% CI, 20.6-NR) among patients treated with BPd (n = 155) compared with 12.7 months (95% CI, 9.1-18.5) for those treated with PVd (n = 147; HR, 0.52; 95% CI, 0.37-0.73; P <.001); 12-month PFS rates were 71% vs 51% in the respective arms. A PFS benefit was also seen consistently across all subgroups and deeper responses were observed with BPd vs PVd. In the BPd arm, patients achieved an ORR of 77% (95% CI, 70%-84%) comprised of a 40% CR or higher rate compared with a 72% (95% CI, 64%-79%) ORR observed in the PVd arm, which was comprised of a 16% CR or higher rate. Very good partial responses or higher occurred in 64% of patients in the BPd arm vs 38% in the PVd arm.

Noa Biran, MD

John Theurer Cancer Center, Hackensack Meridian Health

Noa Biran, MD

"The IMROZ study may potentially change the way we treat transplant-ineligible patients in the newly diagnosed setting [because] the SOC, until now, was the combination of daratumumab/lenalidomide/dexamethasone. The IMROZ study comparing VRd with or without isatuximab in patients with transplant-ineligible, newly diagnosed [disease is] the first time a proteasome inhibitor [has been] incorporated into the treatment regimen for patients with transplant-ineligible myeloma. [Data have] proved both the efficacy and feasibility of the delivery of a quadruplet regimen and [that] a proteasome inhibitor is important, especially in [the treatment of] patients with high-risk disease who are transplant ineligible.”

Abstract 7500

Combination therapy with the anti-CD38 monoclonal antibody isatuximab-irfc (Sarclisa) plus bortezomib, lenalidomide (Revlimid), and dexamethasone (Isa-VRd), followed by Isa-Rd maintenance, led to a statistically significant improvement in PFS vs VRd alone followed by Rd maintenance, in patients with newly diagnosed, transplant-ineligible multiple myeloma.

The interim PFS analysis of the phase 3 IMROZ trial (NCT03319667) indicated that at a median follow-up of 59.7 months, the median PFS was NR in the Isa-VRd arm (n = 265) compared with 54.34 months (95% CI, 45.207-NR) in patients treated with VRd alone (n = 181; HR, 0.596; 98.5% CI, 0.406-0.876; log-rank P = .0005). Notably, the 60-month PFS rates were 63.2% vs 45.2%, respectively. Although OS data are still immature, a favorable trend was observed with a 22.4% reduction in the risk of death for the investigational arm vs control arm.

Skin/Melanoma

Lynn M. Schuchter, MD

Penn Medicine

Lynn M. Schuchter, MD

"The NADINA clinical trial for patients with stage III melanoma where the lymph node is palpable is a practice-changing study. [Data] showed that the combination of immunotherapy [with] nivolumab/ipilimumab was very effective, and maybe now our patients will only need 2 cycles of treatment. When I left [for ASCO], I gave 1 medication; when I have clinic [following ASCO], I will be approaching patients with a different option to consider.”

Abstract LBA2

Neoadjuvant ipilimumab plus nivolumab followed by therapeutic lymph node dissection and response-driven adjuvant therapy demonstrated a highly statistically significant event-free survival (EFS) benefit vs adjuvant nivolumab for patients with macroscopic stage III node-positive melanoma, according to data from the phase 3 NADINA trial (NCT04949113).

The 12-month EFS rate was 83.7% among patients who received the neoadjuvant doublet (n = 212) vs 57.2% among those in the adjuvant therapy arm (n = 211; HR, 0.32; 95% CI, 99.9% CI, 0.15-0.66; P < .0001). Furthermore, nearly 60% of patients in the neoadjuvant arm needed only 6 weeks of therapy, and all subgroups of patients benefitted from receipt of the combination. NADINA is the first trial in melanoma to evaluate a neoadjuvant checkpoint inhibitor approach and the first phase 3 trial to examine a neoadjuvant checkpoint inhibitor combination without chemotherapy for any solid tumor.

Georgina Long AO, BSc, PhD, MBBS, FRACP, FAHMS

Melanoma Institute of Australia, The University of Sydney

Georgina Long AO, BSc, PhD, MBBS,

FRACP, FAHMS

"We have 3 available adjuvant treatments in melanoma: 2 anti–PD-1 drugs and this is our only BRAF-targeted combination available for adjuvant treatment. We did not see an OS benefit in the nivolumab vs ipilimumab trial data, and we’ve yet to see an analysis of OS in the phase 3 KEYNOTE-054 trial [NCT02362594] of pembrolizumab vs placebo. [However], I suspect we will not see an OS [benefit with pembrolizumab vs placebo] because when we treat patients in the stage IV advanced disease setting, we are curing patients then. Therefore, it was amazing to see a separation of the curves in the COMBI-AD trial [data with dabrafenib and trametinib] and a HR of 0.80, although it was not statistically significant.”

Abstract 9500

More than 8 years of follow-up from the phase 3 COMBI-AD trial (NCT01682083) revealed that the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) given adjuvantly continued to numerically improve OS and melanoma-specific survival (MSS) vs placebo in patients with stage III melanoma, although benefits were not statistically significant.

Results of the final analysis showed that, at 8 years, the OS rate with the combination (n = 438) was 71% vs 65% in those who received placebo (n = 432). The median OS was not available (NA) in either the combination (95% CI, 120.7-NA) or placebo (95% CI, NA-NA) arms (HR, 0.80; 95% CI, 0.62-1.01; P = .063). The median MSS in the ITT population was NA in both arms (HR, 0.78; 95% CI, 0.59-1.02); the 8-year MSS rates were 76% with dabrafenib/trametinib and 70% with placebo.