Courtney Marabella

For the treatment of patients with HER2-amplified gastric cancers in addition to those with HER2 moderate-, low-, and non-expressing disease, trastuzumab deruxtecan (Enhertu; DS-8201) has shown to be an effective therapeutic option, according to data presented during the virtual AACR Annual Meeting 2021.

Trastuzumab (Herceptin) and trastuzumab deruxtecan, at various concentrations, demonstrated cytostatic and cytotoxic effects in 49 gastric cancer cell lines examined on the study. Cell proliferation was inhibited by trastuzumab deruxtecan in 55.1% of cell lines (n = 27/49) vs 44.9% (n = 22/49) of cell lines with trastuzumab.

The inhibition rates for these agents were calculated at 10 µg/ml and 100 µg/ml for trastuzumab deruxtecan, and 200 µg/ml for trastuzumab in each HER2 expression group. The ADC was found to inhibit cell proliferation more, at a lower concentration than trastuzumab.

Additionally, the IC50 value of trastuzumab deruxtecan was calculated in 63.3% (n = 30/49) of cell lines, while the IC50 value of trastuzumab was calculated in 1 cell line (NCI-N87). Notably, the cell lines with HER2 overexpression and non-expression proved to be sensitive to the ADC (

“Trastuzumab deruxtecan sensitivity had a significant correlation with HER2 expression level in HER2 overexpression and showed a tendency to correlate in the HER2 moderate-/low-expression level, as well,” lead study author Seo Young Yu, of Yonsei University College of Medicine, said in an oral presentation on the data.

HER2-positive gastric cancer is more aggressive than other gastric cancers, and as such, is associated with a poor prognosis. The humanized anti-HER2 monoclonal antibody trastuzumab has shown clinical benefit in this patient population; however, those with 

-expressing or -amplified disease accounts for only 10% to 20% of all patients with gastric or gastroesophageal cancers.

To overcome this limitation, antibody-drug conjugates like trastuzumab deruxtecan have been developed to enable the direct delivery of a cytotoxic payload to cancer cells. Due to the high membrane permeability of its payload, trastuzumab deruxtecan has a bystander killing effect that can induce the death of neighboring cells.

To date, predictive biomarkers for response to trastuzumab deruxtecan beyond HER2 amplification or overexpression have yet to be studied. As such, in this research, investigators set out to identify a new target for patients with HER-low gastric cancer.

In a panel of 49 gastric cancer cell lines, 26 of which originated from somatic intrachromosomal recombination, HER2 expression was evaluated; genetic alterations were examined via next-generation sequencing, RNA expression through RNA sequencing, and protein expression through immunoblot and flow cytometry analysis.

Using flow cytometry, the 49 gastric cancer cell-line panel was then divided into 3 groups based on HER2 status: HER2 overexpression, HER2 moderate/low expression, and HER2 non-expression. Investigators then compared the anticancer effects of trastuzumab deruxtecan vs trastuzumab through the use of a CCK-8 assay.

Additionally, the sensitivity of trastuzumab deruxtecan vs trastuzumab was evaluated and HER2-related factors like HER expression level, HER2 extracellular domain (ECD), 

 status, were evaluated, according to Yu.

The primary objectives of the study were to identify the correlation between HER2 expression level and the anticancer effect of trastuzumab deruxtecan, as well as to determine the HER2-associated molecule related to the sensitivity of the ADC.

HER2 status for the 49-cell panel was analyzed using 4 breast cancer cell lines for quantitative control: SK-BR-3 (HER2 3+), ZR-75-1 (HER2 2+), MCF-7 (HER2 1+), and HCC1937 (HER2 0). In the group of HER2 moderate-/low-expression, trastuzumab deruxtecan sensitivity showed a tendency to correlate with HER2 expression level.

HER2 ECD was expressed according to HER2 expression level, and most of the cell lines with high expression of HER2 ECD showed sensitivity to trastuzumab deruxtecan. 

 expression was relatively low among the 49 gastric cancer cell lines studied and was not found to be correlated with trastuzumab deruxtecan sensitivity, according to Yu.

Notably, trastuzumab deruxtecan sensitivity was observed, even in the HER2 non-expression group (n = 12/17; 70.6%). As a result of analyzing genetic alterations, RNA and protein expression in this group, RTK amplification was confirmed, and 

 amplification was the most abundant in this group, Yu said. Additionally, 5 of 6 (83.3%) 

-amplified cell lines demonstrated sensitivity to trastuzumab deruxtecan.

Yu S, Park J, Kwon W, et al. Trastuzumab deruxtecan (T-DXd) sensitivity in various levels of HER2 expressing gastric cancer cells. Presented at: AACR Annual Meeting 2021; April 10-15, 2021; Virtual. Abstract 945.

Articles

For the treatment of patients with HER2-amplified gastric cancers in addition to those with HER2 moderate-, low-, and non-expressing disease, trastuzumab deruxtecan has shown to be an effective therapeutic option.

HER2-Expressing Gastric Cancer Cells Respond to Treatment With Trastuzumab Deruxtecan

In a phase 2 trial (NCT01676818) treatment with eribulin led to disease control and a favorable safety profile among patients with recurrent or advanced cervical cancer. According to data presented during the Society of Gynecologic Oncology 2021 Virtual Annual Meeting on Women’s Cancer, however, prior exposure to paclitaxel was associated with decreased response to the agent.

Among 30 evaluable patients, 1 (3%) had a complete response (CR) with eribulin, 5 (17%) had a partial response (PR), and 13 (43%) had stable disease (SD). The clinical benefit achieved with the agent was 63%. Moreover, the median duration of response for patients who achieved a CR or PR (n = 6) with the agent was 4.3 months (95% CI, 2.7-51.1). The median overall survival (OS) was 6.5 months (95% CI, 4.5-12.7), while the median progression-free survival was 2.5 months (95% CI, 1.2-4.2).

Patients who had previously been treated with paclitaxel had less favorable responses to the agent (

 = .002) and a significantly shorter PFS vs those who did not, at 1.2 months and 3.5 months, respectively (

 = .008). The OS was also shorter for patients who had prior paclitaxel vs those who did not receive it, at 4.2 months vs 7.7 months, respectively (

“While the primary end point [of 6-month PFS] was not met, the eribulin may be an option for women with paclitaxel-naïve, recurrent or advanced cervical cancer,” the authors of the poster wrote.

Eribulin, an analog of Halichondrion B, isolated from the Japanese marine sponge Halichondria okadai, induces anticancer activity by way of a tubulin-based antimitotic mechanism. The agent has a unique mechanism of microtubule inhibition that suppresses microtubular growth without impacting microtubular shortening.

Previously, eribulin has demonstrated improved response rates, as well as OS benefit, in patients with pretreated metastatic breast cancer. Moreover, the agent has shown improved OS in patients with previously treated, advanced liposarcoma. Preclinical antitumor activity with eribulin has also been reported in patients with squamous cell carcinoma.

The primary end point for the study was 6-month PFS, while secondary end points included best overall response per RECIST v1.1 criteria, toxicity, and OS. Exploratory end points comprised associations of apoptosis and proliferation markers, unfolded protein response markers, and tubulin subtypes with clinical activity.

A prespecified futility analysis gating stage 2 was established if 0 of 15 patients achieved at least stable disease at 6 months. Thirty evaluable patients would ensure 80% power when the true 6-month PFS was 26% with a 1-sided a of 0.1 or lower. Archival tumor samples were examined via immunohistochemistry for t-protein, tubulin subtypes, 

 and Ki67. Additionally, intensity and percent distribution were assigned by clinical pathologists, and overexpression was determined to be a score of 2 or higher in both parameters.

To be eligible for enrollment, patients had to have advanced or recurrent cervical cancer who had received 1 or fewer prior chemotherapy treatments, had measurable disease, and an ECOG performance status of 0 to 2. From November 2014 through May 2017, a total of 32 patients were enrolled to the study.

Participants were treated with intravenous eribulin at a dose of 1.4 mg/m2 on day 1 and day 8 of a 21-day cycle. Those who achieved a CR, PR, or who had stable disease, were able to continue on therapy; those who experienced peripheral neuropathy of grade 2 or higher that did not improve with dose reduction, disease progression, or a delay of treatment for at least 2 weeks were removed from treatment.

Two patients were unevaluable after having received less than 2 cycles of treatment. The 30 evaluable patients received a median of 4 cycles of treatment (range, 1-74), and the median time on study was 2.7 months (range, 0.6-52.1). The median follow-up time was 52.1 months (range, 29.6-77.3).

The median age of the study participants was 51 years (range, 29-76) and 63% had an ECOG performance status of 1. Additionally, 25% of patients had adenocarcinoma, 3% had adenosquamous carcinoma, 3% had small cell carcinoma, and 69% had squamous cell carcinoma. The majority, or 91%, had received prior chemotherapy treatment. Forty-one percent of patients had previously received cisplatin plus paclitaxel and bevacizumab (Avastin), while 41% had received cisplatin/gemcitabine, 7% had prior carboplatin/paclitaxel, and 10% had cisplatin with or without pemetrexed or capecitabine only. Moreover, 66% of patients had recurrent disease, and 56% had not received prior treatment with paclitaxel. Most patients had not previously received radiation treatment.

Correlative studies showed that βII-tubulin and βIII-tubulin, as well as BAX expression were predictors of response to eribulin for this patient population. Specifically, patients who did not overexpress βII-tubulin and BAX were more likely to respond to the agent (

 = .002, respectively). Univariate analyses revealed that PFS was shorter in patients with βII-tubulin overexpression, at 1.2 months (95% CI, 0.9-2.6), and in patients with BAX overexpression, at 1.2 months (95% CI, 1.1-2.6). OS was shorter in those with βIII-tubulin and BAX overexpression, at 6.4 months (95% CI, 3.1-12.7) and 4.3 months (95% CI, 2.7-6.5), respectively.

In terms of safety, 2 patients were taken off of the study after experiencing grade 3 paresthesia after 7 cycles and 74 cycles of treatment each. Additionally, 5 patients required a dose reduction while on treatment, while 3 patients required 2 dose reductions.

The most common grade 3 or higher adverse effects were anemia (38%), decreased neutrophil count (22%), and decreased white blood cell count (19%).

Garcia-Sayre J, Lin Y, Matuso K, et al. Phase II trial of eribulin in advanced/recurrent cervical cancer. Presented at: 2021 SGO Virtual Annual Meeting on Women’s Cancer; March 19-25, 2021; Virtual. Accessed March 19, 2021.

In a phase 2 trial treatment with eribulin led to disease control and a favorable safety profile among patients with recurrent or advanced cervical cancer. 

Eribulin Induces Disease Control in Advanced/Recurrent Cervical Cancer

In a phase 3 study, hematopoietic recovery following myeloablative transplantation with omidubicel was faster than standard myeloablative umbilical cord blood (UCB) transplantation and correlated with promising clinical benefit, according to data presented during the 2021 Transplantation & Cellular Therapy Meetings.

Transplantation with the investigational advanced cell therapy also resulted in fewer early bacterial or invasive fungal infections and fewer days in the hospital, during the first 100 days post transplantation.

Moreover, no excessive toxicity was observed with omidubicel versus standard UCB transplantation, and long-term follow-up data from recent studies suggest durable engraftment of greater than 10 years with 

“We believe that these data suggest omidubicel as a new standard of care for patients eligible for umbilical cord blood transplantation,” study author Mitchell Horwitz, MD, a cell therapy and hematologic malignancies specialist at Duke Health, said during an oral presentation of the data. “[The sponsor], Gamida Cell, will be submitting these data for regulatory review in the coming months.”

The use of UCB as a stem cell source for allogeneic transplantation comes with several advantages: it is a readily available source, there is less evidence of chronic graft-versus-host-disease (GVHD) compared with matched unrelated donor transplantation, it exhibits potent antitumor activity, and it has been utilized for almost 30 years in the field.

The primary disadvantage of this treatment is that it can result in a low stem cell dose, which can lead to delayed hematopoietic and immunologic recovery and increased transplant-related morbidity and mortality, said Horwitz. This approach may also result in increased resource utilization, particularly in adult transplant recipients. However, 

 expansion of the umbilical cord blood graft prior to transplantation may present a possible solution to these limitations, according to Horwitz.

Omidubicel is a cryopreserved allogeneic stem cell-based product comprised of 

 expanded UCB-derived CD34-positive progenitor cells and non-expanded myeloid and lymphoid cells. It is derived from a single, best matched UCB unit, selected by the transplant center, Horwitz explained.

After CD133 selection, a negative T-cell containing fraction is cryopreserved, and the CD133-positive fraction is cultured for 21 days in the presence of nicotinamide, which is the critical point of the culture system, Horwitz added. Nicotinamide plays a key role in metabolic reprogramming of cells, is a master regulator of NAD-related signaling pathways, is directly involved in control of redox-sensitive enzymes, and preserves cellular functionality and phenotype during expansion.

Previously, a phase 1/2 study demonstrated robust hematopoietic reconstitution with omidubicel. For the phase 3 trial, investigators sought to evaluate the efficacy of omidubicel compared with standard UCB in patients with hematologic malignancies.

To be eligible for enrollment, patients had to be between the ages of 12 years and 65 years, have a high-risk hematologic malignancy, be a candidate for allogeneic bone marrow transplantation, and not have a matched donor.

Participants in the intent-to-treat (ITT) population were randomized to receive omidubicel (n = 62) versus standard UCB (n = 63). Of those patients, 108 were transplanted with either omidubicel (n = 52) or standard UCB (n = 56); these patients comprised the as-treated population of the trial.

Cord blood units were selected before randomization and patients were stratified by treatment center, disease risk index (DRI), age, and intent to perform a single or double cord transplant in the control arm. Myeloablative conditioning was limited to either a chemotherapy-only regimen or 2 total body irradiation (TBI)–based regimens.

The primary end point of this study was time to neutrophil engraftment, and secondary end points included time to platelet engraftment, the incidence of grades 2/3 invasive bacterial or fungal infections at 100 days, and days alive out of the hospital following the first 100 days post transplantation.

The patient demographics were well balanced, according to Horwitz. The median age of participants in the ITT population was 41.5 years and 57.5% were male. The majority, or 48%, had acute myeloid leukemia, 32.5% had acute lymphocytic leukemia, 7.5% had myelodysplastic syndromes, 5% had chronic myeloid leukemia, 4% had lymphoma, and 3% had a rare leukemia. Additionally, the majority, or 58%, of patients were White, 16% were Black, 13.5% were Asian, and 13% were other.

“Half of the patients received a TBI-containing myeloablative conditioning regimen,” noted Horwitz.

When looking at graft characteristics, regarding the total CD34-positive cell content, the omidubicel unit was expanded to a median of 6.6 x 108 CD34-positive cells, noted Horwitz; this provided patients with a median CD34-positive cell dose of 9.0 x 106 cells/kg, “a cell dose larger than that collected from many healthy adult stem cell donors,” said Horwitz. In contrast, those in the control arm received a median CD34-positive cell dose of 0.3 x 106 cells/kg.

Median time to neutrophil engraftment in the ITT population was 12 days (95% CI, 10-15) in the omidubicel ITT arm, and 22 days (95% CI, 19-25) in the control ITT arm (

 <.001). “This difference was highly statistically significant,” noted Horwitz.

Moreover, in the AT population who received the omidubicel engraftment, the median time to neutrophil recovery was 10 days (95% CI, 8-13) versus 20.5 days (95% CI, 18-24) in those who received the control (

 <.001). The cumulative incidence of neutrophil engraftment was 96% in those who received omidubicel versus 89% for those who received the control.

Platelet engraftment by day 42 was achieved in 55% of those in the ITT population who received omidubicel versus 35% of those who received the control, translating to a 20% difference in cumulative incidence between the arms (

 = .028). Additionally, the cumulative incidence of platelet engraftment in the AT population at day 100 was 83% at a median of 37 days (95% CI, 33-42) with omidubicel versus 73% at a median of 50 days (95% CI, 42-58) with the control (

 <.023). “This was also a difference that was statistically significant,” noted Horwitz.

Moreover, patients in the ITT population who received omidubicel were found to be less likely to develop grade 2/3 bacterial or invasive fungal infection by day 100, added Horwitz. The incidence of these infections was 37% in the investigative arm versus 57% in the control arm (

“In an unexpected, but positive finding, recipients randomized to omidubicel were less likely to experience grade 3, severe viral infections,” reported Horwitz. The incidence of these infections in the omidubicel arm was 10% versus 26% in the control arm. “[We also saw a] significant reduction in human herpesvirus 6 and cytomegalovirus in those who received omidubicel,” added Horwitz.

Investigators also conducted a quantitative lymphocyte analysis and showed that there were significant differences in B cell and natural killer cell recovery, said Horwitz; this was found to favor patients who received omidubicel.

Moreover, patients in the ITT population who were given omidubicel spent a median of 60.5 days alive and out of the hospital during the first 100 days post transplant versus 48.0 days in those who received the control (

 = .005); this translated to about a 13-day difference and “it was due primarily to a shorter initial period of hospitalization,” explained Horwitz.

No difference in grade 2 or higher acute GVHD was observed between the arms. Fifty-six percent of patients on the investigative arm experienced grade 2 to grade 4 acute GVHD versus 43% of those on the control arm. Grade 3 and 4 acute GVHD was reported in 8% of patients who received omidubicel versus 12% of those given the control.

“No difference in the incidence of chronic GVHD was observed between the 2 arms [at 1 year],” added Horwitz; here, the 

The cumulative incidence of non-relapse mortality at 210 days post randomization “trended slightly lower” for those who received omidubicel compared with those who received the control, at 11% versus 24%, respectively (

 = .09). Incidence of relapse at 15 months post randomization was 25% in the investigative arm versus 17% in the control arm (

 = .32), although this difference was not determined to be statistically significant.

No differences in the probability of disease-free survival (

 = .16) were observed between the arms. “It should be noted that the study was not powered to detect differences in these end points and the 10-month median follow-up also compromised analysis of these end points,” concluded Horwitz.

Horwitz ME, Stiff P, Rezvani AR, et al. Improved clinical outcomes with omidubicel versus standard myeloablative umbilical cord blood transplantation: results of a phase III randomized, multicenter study. Presented at: 2021 Transplantation and Cellular Therapy Meetings; February 8-12, 2021; Virtual. Abstract 34.

Omidubicel was faster than standard myeloablative umbilical cord blood transplantation and correlated with promising clinical benefit, according to phase 3 data.

Omidubicel May Replace Current Standard in UCB Transplant Eligible Hematologic Malignancies

In patients with resectable, stage II-IIIB non–small cell lung cancer (NSCLC) whose tumors harbor 

mutations, neoadjuvant osimertinib (Tagrisso) will be administered as a single agent or in combination with platinum-based chemotherapy compared with chemotherapy alone in the NeoADAURA trial (NCT04351555).

The trial design was presented at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer (WCLC).

The primary end point of the study is focused on evaluating major pathological response (MPR), which is defined as less than or equal to 10% of residual cancer cells in the lung tumor specimen following surgery per central assessment. The study sample was based on approximately a 90% power to identify a statistically significant 20 percentage point difference in MPR, with a 2-sided overall significance level of 5% when assuming a 20% MPR in the control arm.

One interim futility analysis will be performed based on MPR, the smallest treatment effect of absolute difference of 6% versus the control arm, will be performed; this will happen after approximately half of the study participants have undergone surgery.

Key secondary end points for the study include event-free survival, pathological complete response, downstaging, disease-free survival (DFS), overall survival (OS), MPR in patients with or without detectable 

mutations in plasma circulating tumor DNA at screening, disease-related symptoms and health-related quality of life, as well as safety and tolerability.

About 30% of patients with NSCLC present with resectable disease, and the primary treatment for this population is curative surgery; however, prognosis after surgery continues to be poor. Neoadjuvant or adjuvant chemotherapy is recommended for certain patients with resectable stage 3 disease, irrespective of 

status, as this has been proven to have clinical benefit.

For example, results from a prior phase 3 study showed that preoperative chemotherapy significantly improved outcomes for patients with stage IIB/IIIA NSCLC compared with surgery alone. The progression-free survival (PFS) rate at 3 years was 36.1% with preoperative chemotherapy versus 55.4% with surgery alone (

 = .002). However, improved treatment options for patient with stage 2-3 disease are still needed, as the 5-year probability for OS is 65% for those with stage IIA disease, 56% for those with stage IIB disease, 41% for stage IIIA disease, and 24% for stage IIIB disease.

The third-generation, irreversible EGFR TKI osimertinib was developed to inhibit 

 sensitizing mutations and T790M resistance mutations, as well as to have central nervous system (CNS) activity. In the pivotal phase 3 ADAURA trial (NCT02511106), the agent resulted in a statistically significant improvement in DFS at 24 months (HR, 0.20; 99.12% CI, 0.14-0.30; 

 This benefit led to the December 2020 FDA approval of osimertinib for use as an adjuvant treatment following tumor resection in patients with NSCLC whose tumors harbor 

 mutations. Moreover, updated data presented during the 2020 ESMO Virtual Congress showed that the EGFR TKI reduced the risk for CNS death or progression by 82% in this patient population.

Recent studies have suggested that treatment with an EGFR TKI treatment could be feasible in the neoadjuvant setting in that it could potentially result in reduced tumor burden and eliminate micrometastases.

“Combining an EGFR TKI and chemotherapy in the neoadjuvant setting may optimize tumor downstaging and micrometastatic eradication,” the NeoADAURA authors wrote in the poster. “In advanced disease, combining an EGFR TKI with chemotherapy has resulted in improved PFS versus EGFR TKI [monotherapy].”

Additionally, results from a recent phase 2 study (NCT03433469) indicated that neoadjuvant osimertinib was well tolerated in patients with stage I-IIIA NSCLC. Participants went to surgical resection without experiencing any unscheduled delays.

Because of the favorable efficacy and tolerability data that have been reported with osimertinib in the advanced and adjuvant settings, investigators have set out to examine the agent in the neoadjuvant setting for patients with resectable disease.

The randomized, controlled, multicenter NeoADAURA trial will enroll a total of 351 patients with resectable, stage II-IIIB NSCLC whose tumors harbor 

 mutations. Participants will be stratified by disease stage (II vs III), ethnicity (non-Asian vs Chinese vs other Asian), and type of 

 mutation (exon 19 deletion or L858R deletion).

To be eligible for enrollment, patients have to be aged 18 years and have primary nonsquamous stage II-IIIB N2 NSCLC with 

mutations confirmed on their baseline tumor biopsy sample, or primary NSCLC that has been deemed to be completely resectable by a multidisciplinary team, including a thoracic surgeon. Patients must also have an ECOG performance status of 0-1, acceptable organ and bone marrow function, and a life expectancy of greater than 6 months prior to randomization.

f patients previously received systemic therapy for their disease, had mixed small cell and NSCLC histology, underwent preoperative radiotherapy, or had bulky N2 disease, they could not participate. Moreover, patients who were candidates for segmentectomies or wedge resections only were also excluded. If they had T4 tumors infiltrating the aorta, esophagus, and/or heart; a history of, or current, interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis; severe or uncontrolled systemic diseases or active infections; a history of allogeneic organ transplantation, primary immunodeficiency, or another primary malignancy, among other criteria; they could not participate.

Patients will be randomized 1:1:1 to receive either daily placebo plus investigator’s choice of pemetrexed at 500 mg/m2 plus carboplatin AUC5 mg/ml/min or cisplatin at 75 mg/m2 given in 3 cycles every 3 weeks; osimertinib at a daily dose of 80 mg plus investigator’s choice of pemetrexed plus carboplatin or cisplatin at the same dosing schedule or osimertinib at a daily dose of 80 mg for 9 weeks. The first 2 arms will be double-blinded, while the third arm will be open-label, sponsor-blind.

After patients received treatment, they will go on to undergo surgery, be evaluated for MPR and pCR, and then go on to receive adjuvant treatment with investigator’s choice of therapy. Participants will be followed for OS for 5 years after surgery. Investigators will evaluate patients 12 weeks and 24 weeks following surgery, and then every 24 weeks thereafter, until disease recurrence or consent is withdrawn. Notably, osimertinib will be offered to all patients who complete surgery, with or without post-surgical chemotherapy, for up to 3 years, or until disease recurrence.

In the trial, investigators will also evaluate health resource use by utilizing the EQ-5D-5L health state utility index and metabolic response per PERCIST criteria. They will also evaluate genetic, gene expression, and proteomic markers, as well as examine the relationship between molecular evidence of disease and clinical response end points. Other exploratory end points of the trial include evaluating the relationship between molecular aberrations and response and learning more about human leukocyte antigen alleles linked with susceptibility to drug-related adverse effects.

Enrollment for the NeoADAURA trial began in December 2020. The trial will be available in 23 countries including the United States, Mexico, Brazil, Austria, Germany, Italy, the United Kingdom, Russia, China, India, South Korea, and Vietnam. Data from the prior MPR analysis are anticipated to be available in 2024.

Tsuboi M, Weder W, Escriu C, et al. Neoadjuvant osimertinib with/without chemotherapy vs chemotherapy for EGFR mutated resectable NSCLC: NeoADAURA. Poster presented at: 2021 World Conference on Lung Cancer Singapore; January 28-31, 2020; Singapore. Accessed January 28, 2021. 

Wu Y-L, Tsuboi M, He J, et al. Osimertinib in resected 

. 2020;383(18):1711-1723. doi:10.1056/NEJMoa2027071

Tsuboi M, Wu Y-L, He J, et al. Osimertinib adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) NSCLC (ADAURA): central nervous system (CNS) disease recurrence. 

. 2020;31(suppl 6):S1378. doi:10.1016/j.annonc.2020.10.349

n patients with resectable, stage II-IIIB non–small cell lung cancer whose tumors harbor EGFR mutations, neoadjuvant osimertinib will be administered as a single agent or in combination with platinum-based chemotherapy compared with chemotherapy alone in the NeoADAURA trial

Courtney Marabella | Authors

Articles

HER2-Expressing Gastric Cancer Cells Respond to Treatment With Trastuzumab Deruxtecan

Eribulin Induces Disease Control in Advanced/Recurrent Cervical Cancer

Omidubicel May Replace Current Standard in UCB Transplant Eligible Hematologic Malignancies

NeoADAURA Trial Launches With Plans to Assess Neoadjuvant Osimertinib in Resectable EGFR+ NSCLC