Clinicians tasked with treating patients with non–small cell lung cancer (NSCLC) may soon be gaining an additional therapeutic target, this one directed at CEACAM5. Considering the positive preclinical and early-phase findings observed with tusamitamab ravtansine (SAR408701), investigators have initiated the phase 3 CARMEN-LC03 trial (NCT04154956) to further confirm the utility of the marker for this patient population.

CEACAM5 is not highly expressed in several normal tissues, including colon, esophagus, and head and neck. However, the protein is often highly expressed in a few tumor types, such as gastrointestinal, breast, and lung.

“CEACAM5 is present in about 25% of lung cancers in high expression, and another 20% or so in moderate expression,” Martin F. Dietrich, MD, PhD, a medical oncologist at Florida Cancer Specialists & Research Institute and an assistant professor of internal medicine at the University of Central Florida in Orlando, said in an interview with 

. “We see a differentiator there between surface expression on tumor cells and surface expression on normal tissue. We see some expression in squamous cells as well, but not nearly as commonly as in the nonsquamous histologies.”

One CEACAM5-directed agent making waves in the NSCLC space is the novel antibody-drug conjugate (ADC) tusamitamab ravtansine, which is engineered using a humanized monoclonal antibody and a cytotoxic maytansinoid, DM4. The monoclonal antibody binds to CEACAM5, and the maytansinoid targets CEACAM5-expressing tumor cells. In preclinical studies, the agent was proven to selectively bind to CEACAM5 in human tissue and displayed cytotoxic activity, leading investigators to mark it as a promising treatment option for patients with CEACAM5-positive tumors.

Tusamitamab Ravtansine Performs Well in Early-Phase Trial

Following preclinical study, investigators initiated an ongoing phase 1/2 trial (NCT02187848) to evaluate tusamitamab ravtansine in patients with solid tumors. Eligible adult patients were required to have and ECOG performance status of 1 or 0 and locally advanced/metastatic solid tumors that expressed or were likely to express CEACAM5.

In the dose-escalation phase 1 portion of the trial, 31 patients received tusamitamab ravtansine at doses ranging from 5 to 150 mg/m2, given every 2 weeks intravenously (IV). A dose-limiting toxicity of reversible grade 3 microcystic keratopathy was reported in 3 of the 8 patients who received tusamitamab ravtansine 120 mg/m2 and in 2 of the 3 patients who received 150 mg/m2. Investigators determined the maximum-tolerated dose (MTD) of tusamitamab ravtansine to be 100 mg/m2 IV every 2 weeks.

As of January 2020, 92 patients were treated at the MTD in the nonsquamous NSCLC cohort of the trial. Twenty-eight of these patients were moderate expressors of CEACAM5 (immunohistochemistry [IHC] ≥ 2+ on 1%-50% of tumor cells) and 64 were high expressors (IHC ≥ 2+ on ≥ 50% of tumor cells). The median age of the treated patients was 62.5 years (range, 31-91) and the median number of prior lines of therapy for advanced disease was 3 (range, 1-10). Most patients were men (51.1%) and most had an ECOG performance status of 1 (71.7%).

Findings from the trial showed that the overall response rate (ORR) among moderate expressors was 7.1% (95% CI, 1.98%-22.65%), with all responses being confirmed partial responses (PRs). Additionally, 53.6% of patients experienced stable disease (SD), the disease control rate (DCR) was 60.7%, and 35.7% had progressive disease (PD). One patient in this subgroup was not evaluable (NE) at the time of the analysis.

Comparatively, patients in the high-expressor cohort achieved an ORR of 20.3% (95% CI, 12.27%-31.71%), with all responses being PRs. Patients in this subgroup experienced SD at a rate of 43.8%, a DCR of 64.1%, and 32.8% had PD. Two patients were NE.

In the overall nonsquamous NSCLC cohort, the most common treatment-emergent adverse effects (TEAEs) were asthenia (38.0%), keratopathy/keratitis (38.0%), peripheral neuropathy (26.1%), dyspnea (23.9%), and diarrhea (22.8%). Common hematologic toxicities included leukopenia (14.4%), thrombocytopenia (13.3%), and neutropenia (4.4%). Dose modifications due to TEAEs occurred in 33.7% of patients, 10.9% of which were associated with keratopathy/keratitis. Grade 3 or greater TEAEs were reported in 47.8% of patients.

Corneal TEAEs leading to dose modification occurred in 27.2% of patients. Ten of these patients experienced at least 1 dose reduction, and 1 patient was forced to discontinue treatment. The median time to recovery from this type of TEAE was 18.5 days (range, 2-82).

“The most common notable adverse effect is keratopathy, followed by peripheral neuropathy, as you would expect from a tubulin inhibitor,” Dietrich said. “[There are also] some GI [gastrointestinal] toxicities, not untypical for chemotherapy. The keratitis/keratopathy is an on-target effect and will require monitoring and management.”

Additional data from the trial, which encompassed patients treated over a long term, were presented at the 2022 American Society of Clinical Oncology Annual Meeting. In this analysis, the study authors focused on patients who had undergone treatment with tusamitamab ravtansine for at least 12 months as of December 2021.

Findings showed that 24 patients were treated for at least 6 months, 15 patients for at least 9 months, 11 patients for at least 12 months, 6 patients for at least 24 months, and 2 patients for at least 42 months. Five patients remained on treatment at the data cutoff, 1 of whom has remained on treatment for more than 52 months. Among patients who were treated for at least a year, the median duration of treatment was 26.6 months (range, 12.1-45.3).

Patients in this cohort had a median age of 61 years (range, 41-91), and 81% had high CEACAM5 expression. The median number of prior regimens for advanced disease was 2 (range, 1-6), with 54.5% of patients having received prior anti–PD-1/PD-L1 therapy and 45.5% having received antitubulin therapy.

Of the patients who experienced a PR in the January 2020 analysis (n = 15), PR was still reported in 67% of patients who were treated for at least 6 months, 53% of patients who were treated for at least 9 months, and 47% of patients who were treated for at least 1 year. Additionally, patients who were treated for at least 1 year had better ECOG performance status and underwent fewer prior treatment regimens compared with the overall group. PR was also found to occur regardless of CEACAM5 expression level in patients who received tusamitamab ravtansine for at least 1 year.

In terms of safety, investigators noted that only 1 patient who was treated for at least 12 months was forced to discontinue treatment due to a TEAE, which was breast cancer. The most common TEAEs were corneal events; any-grade corneal TEAEs occurred in 73% of patients, with 36% of these being grade 3 or greater. Treatment was delayed or the dose was reduced in 7 patients, and no corneal TEAEs were deemed serious or led to treatment discontinuation.

Investigators concluded that heavily pretreated patients exhibited a durable and frequently sustained response to treatment with tusamitamab ravtansine, adding that further clinical development of the agent is warranted.

“In the second-line [setting], we’ve had very transient progress with immunotherapies that then moved up into the first-line space,” Dietrich said. “So, that makes it a wide-open field. There’s been really no progress in the second-line setting beyond targeted therapies, such as 

 exon 20 inhibitors and docetaxel with or without ramucirumab has remained the comparative benchmark. [This agent] is going to change the way we’re going to apply our therapies in the second line dramatically and open a new set of opportunities for patients. In fact, the second-line dynamic is going to also [affect] how are we going to approach the future in the first-line setting, because we’ve certainly run up against a wall in intensification of immunotherapies.”

Pivotal CARMEN-LC03 Trial Aims to Validate Tusamitamab Ravtansine

CARMEN-LC03 will enroll approximately 450 adult patients with NSCLC and an ECOG performance status of 1 or 0 who have experienced disease progression following treatment with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI). Additionally, patients must have exhibited CEACAM5 expression in at least 50% of tumor cells at an intensity of at least 2+ to be included in the study

“This will be the first usage of this regimen in the second-line setting,” Dietrich noted.

Patients enrolled on the open-label trial will be randomly assigned to receive tusamitamab ravtansine monotherapy or the standard-of-care treatment docetaxel. Treatments will be given at a dose of 100 mg/m² IV every 2 weeks or 75 mg/m² IV every 3 weeks, respectively. Patients will be stratified based on ECOG performance status, previous ICI treatment, and geographic region.

The coprimary end points of the study are PFS and OS. Secondary end points include ORR, health-related quality of life, safety, and DOR. The trial is recruiting patients and has an anticipated completion date of August 2024.

“There are a number of additional trials that are looking at combining this agent with an anti-VEGF agent to match the frequent reality of ramucirumab upon disease progression in first line,” Dietrich said. “There are also first-line trials [such as] CARMEN-LC05 [NCT04524689], which is a combination with pembrolizumab [Keytruda] plus carboplatin. Those are going to be the developmental pipeline. We’re expecting this agent to be approved sometime in early 2024 and be available for patients shortly thereafter as a new opportunity for treatment.”

Gazzah A, Bedard PL, Hierro C, et al. Safety, pharmacokinetics, and antitumor activity of the anti-CEACAM5-DM4 antibody-drug conjugate tusamitamab ravtansine (SAR408701) in patients with advanced solid tumors: first-in-human dose-escalation study. 

. 2022;33(4):416-425. doi:10.1016/j.annonc.2021.12.012

Johnson ML, Chadjaa M, Yoruk S, Besse B. Phase III trial comparing antibody-drug conjugate (ADC) SAR408701 with docetaxel in patients with metastatic non-squamous non-small cell lung cancer (NSQ NSCLC) failing chemotherapy and immunotherapy. 

. 2020;38(suppl 15):TPS9625. doi:10.1200/JCO.2020.38.15_suppl.TPS9625

Decary S, Berne PF, Nicolazzi C, et al. Preclinical activity of SAR408701: a novel anti-CEACAM5-maytansinoid antibody-drug conjugate for the treatment of CEACAM5-positive epithelial tumors. 

. 2020;26(24):6589-6599. doi:10.1158/1078-0432.CCR-19-4051

Gazzah A, Ricordel C, Cousin S, et al. Efficacy and safety of the antibody-drug conjugate (ADC) SAR408701 in patients (pts) with non-squamous non-small cell lung cancer (NSQ NSCLC) expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). 

. 2020;38(suppl 15):9505. doi:10.1200/ JCO.2020.38.15_suppl.9505

Ricordel C, Barlesi F, Cousin S, et al. Safety and efficacy of tusamitamab ravtansine (SAR408701) in long-term treated patients with nonsquamous non-small cell lung cancer (NSQ NSCLC) expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). 

. 2022;40(suppl 16):9039. doi:10.1200/ JCO.2022.40.16_suppl.9039

SAR408701 versus docetaxel in previously treated, carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) positive metastatic non-squamous non-small-cell lung cancer patients (CARMEN-LC03). ClinicalTrials.gov. Updated January 13, 2023. Accessed February 8, 2023. https://clinicaltrials.gov/ct2/show/NCT041549

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Clinicians tasked with treating patients with non–small cell lung cancer may soon be gaining an additional therapeutic target, this one directed at CEACAM5. 

CEACAM5-Directed Tusamitamab Ravtansine Progresses to Phase 3 Trial in NSCLC

Tusamitamab ravtansine (SAR408701), an antibody-drug conjugate (ADC) that targets CEACAM5, could expand the treatment armamentarium for patients with CEACAM5-positive nonsquamous non–small cell lung cancer (NSCLC), according to Chao H. Huang, MD, FACP.

The phase 2 CARMEN-LC05 trial (NCT04524689), which is currently enrolling patients with CEACAM5-positive, advanced or metastatic nonsquamous NSCLC, will investigate tusamitamab ravtansine in 5 arms. One arm will receive the ADC plus pembrolizumab (Keytruda), and the other arms will receive tusamitamab ravtansine plus pembrolizumab and either cisplatin or carboplatin with or without pemetrexed (Alimta). This study’s primary end points are safety and the determination of the recommended doses of tusamitamab ravtansine in this population.

“[Tusamitamab ravtansine may not become a] substitute [for chemotherapy], but it could be another option in lung cancer treatment,” Huang said in an interview with 

In the interview, Huang explained the unique properties of tusamitamab ravtansine, obstacles that arise when testing for CEACAM5 expression, and where the agent may fit among the current chemoimmunotherapy options in the treatment paradigm.

Huang is an associate professor and clinical professor of medical oncology at The University of Kansas Medical Center in Kansas City.

: How does the mechanism of action of tusamitamab ravtansine contrast with current targeted treatment options using TKIs?

: [Tusamitamab ravtansine] is an ADC that recognizes CEACAM5. This monoclonal antibody links with several molecules of chemotherapy. The idea is that when you deliver this ADC, it will seek out the tumor bed, bind to the protein, and deliver the chemotherapy to the tumor as opposed to having more of a systemic effect.

[This agent is] similar to ado-trastuzumab emtansine [Kadcyla] for breast cancer, which targets HER2 with chemotherapy, as well as [fam-trastuzumab deruxtecan-nxki (Enhertu) in] the DESTINY-Lung trials, which is also an ADC targeting HER2. [These agents are] different from TKIs because [they are not comprised of] small molecules. [Instead, they contain] monoclonal antibodies. TKIs are chemicals that enter the cancer cells, bind to the tyrosine kinase domain of the receptor, and shut it off. Monoclonal antibodies bind to the extracellular domain of the cell, where the protein is expressed. [Tusamitamab ravtansine is different from TKIs because it] doesn’t target a specific mutation, it targets the protein. It’s also delivered intravenously, as opposed to TKIs, [which are administered] orally.

Based on prior literature, is CEACAM5 found more commonly in certain subsets of NSCLC, and could that information guide treatment strategies?

It’s more expressed in adenocarcinoma and would potentially be a greater target in non–small cell adenocarcinoma histology. It probably does not have as high an expression in squamous cell [disease], therefore, it might be a more viable target in adenocarcinoma as opposed to squamous cell. [This indicates that] we need more options for squamous cell [disease].

Is this marker best identified in tissue or blood and why? What challenges can arise with identifying it?

CEACAM5 [is most often detected] in tissue. Currently, the clinical trial protocol is to send the tumor biopsy to a central lab to identify expression of this gene through immunohistochemistry [IHC]. [There are different classifications for CEACAM5 expression level based on] the percentage of cancer cells that express it. [Tumors can have] low, intermediate, or high expression. [The CARMEN-LC05 trial defines CEACAM5 expression as an IHC assay where at least 1% of the cells express the gene.]

Because [CEACAM5 detection] requires tissue, testing for it can sometimes be a challenge. Nowadays, when we do a lung cancer biopsy, we want to do molecular testing, and doing that sometimes exhausts the biopsy sample. It could be a challenge to use additional tissue for this IHC [analysis].

[Additionally], although this antibody [test] can be acquired commercially, this testing is not yet standardized, so we cannot just order it in our lab and get it done. Currently, the company uses 1 specific platform, and [testing is performed] by a central lab. In the future, once this platform is validated, [testing] can potentially be done in any lab, but our challenge right now is getting the tissue and sending it to the central lab, which can have a turnaround time of 7 to 10 days.

Testing in the blood is a bit different [because it] relies on the presence of circulating tumor cells. First, you need to identify the cancer cells in the blood, then isolate them and do IHC staining on them. Technically, it can be done, but the challenge is finding those circulating tumor cells. If you don’t find them, you cannot do the testing. Even if you do the testing, [you may not truly find] cancer cells, meaning you could have a false positive result.

The more reliable and accurate test is done in tissue. However, in the future, we may develop or refine blood-based testing to better identify CEACAM5 expression.

What is the rationale for the CARMEN-LC05 trial, and why is this research important in the context of the current treatment landscape?

This is a frontline trial using tusamitamab ravtansine in combination with pembrolizumab or pembrolizumab and platinum-based chemotherapy, with or without pemetrexed. [We are adding] the study drug, this ADC, to a checkpoint inhibitor with or without platinum and pemetrexed. [This study is] essentially [evaluating the efficacy of] giving 4 drugs vs eliminating pemetrexed. [Tusamitamab ravtansine could] be a substitute for pemetrexed, or even a substitute for both carboplatin and pemetrexed.

[This trial is] in patients [with tumors that] express CEACAM5. [CARMEN-LC05] is currently ongoing, and we have accrued some patients. The challenge has been finding patients with CEACAM5 expression. We have screened close to 20 patients, and we found about 3 patients with [CEACAM5 expression]. Many of the patients we screened did not have sufficient tissue, so we couldn’t have the testing done. Because we need the tissue for both the molecular testing and the standard of care, by the time we test for this protein, we may not have enough tissue.

Tusamitamab ravtansine is also being studied in the phase 3 CARMEN-LC03 (NCT04154956) and phase 2 CARMEN-LC06 (NCT05245071) trials. Based on all this research, where do you believe this agent will demonstrate the most activity and why?

Those trials are in the second line. This drug will probably be effective regardless of the line of therapy, in both the first and second lines. Other ADCs, like those in breast cancer, were first found to be active in metastatic disease and are now moving to the frontline and even adjuvant settings.

In lung cancer, we’ll probably see [a similar pattern] with [tusamitamab ravtansine]. [It might be] effective in the second-line setting, and it’s been tested in the frontline setting. Once all these studies mature, this agent will be a potential option in either the first- or second-line settings. If the cancer expresses this gene, meaning the target is present, the drug should be active.

One issue still to be worked out is the adverse effect [AE] profile of this agent. One AE is uveitis, an eye irritation. Withholding the drug and managing patients’ symptoms seems to resolve it, and it doesn’t seem to recur when rechallenging these patients with the same drug. We need more education and comfort from physicians [regarding these AEs when we] start using this drug in the future.

Pending positive data from the CARMEN trials, do you see this ADC-based regimen being favored over current chemoimmunotherapy combinations?

It might not be favored, but it could certainly be an add-on and a potential option. In patients who need chemotherapy added to checkpoint inhibitors, if [CARMEN-LC05] proves that tusamitamab ravtansine can take the place of carboplatin and pemetrexed, it might be better to use the ADC instead of giving 2 chemotherapies. Maybe that will reduce the toxicity.

The demise of chemotherapy is being greatly exaggerated. We are still using it. Despite the existence of TKIs and some of the other antibody therapies, we still need to use chemotherapy once patients progress on TKIs or monoclonal antibodies. Chemotherapy will not go away. It may be used in conjunction with some of these new drugs or in sequence.

What other investigational approaches in this population would you like to highlight?

I have been working with the company to propose a potential trial using tusamitamab ravtansine as consolidation after chemoradiation. Although this is an idea in development, [this agent] may be used in stage III disease in the future. Future programs or projects [may investigate this agent] in the adjuvant or neoadjuvant settings once it has been proven active and the AE profile is found to be manageable and without major issues.

Tusamitamab ravtansine (SAR408701) in combination with pembrolizumab and tusamitamab ravtansine (SAR408701) in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in patients with NSQ NSCLC (CARMEN-LC05) (CARMEN-LC05). ClinicalTrials.gov. Updated December 13, 2022. Accessed January 11, 2023. 

https://clinicaltrials.gov/ct2/show/NCT04524689

Tusamitamab ravtansine, an antibody-drug conjugate that targets CEACAM5, could expand the treatment armamentarium for patients with CEACAM5-positive nonsquamous non–small cell lung cancer.

Tusamitamab Ravtansine Is Under Investigation in CEACAM5+ Nonsquamous NSCLC

Targeting CEACAM5 with the antibody-drug conjugate (ADC) tusamitamab ravtansine (SAR408701) may improve treatment outcomes in patients with CEACAM5-positive, nonsquamous non–­small cell lung cancer (NSCLC), according to Alexander Spira, MD, PhD, FACP, who emphasized the importance of testing for the target through tissue-based assays.

The phase 2 CARMEN-LC05 trial (NCT04524689) is investigating the ADC tusamitamab ravtansine plus pembrolizumab (Keytruda) and tusamitamab ravtansine plus pembrolizumab and platinum-based chemotherapy with or without pemetrexed (Alimta) in patients with CEACAM5-positive, advanced or metastatic nonsquamous NSCLC.

 Additionally, tusamitamab ravtansine is being studied in the phase 3 CARMEN-LC03 (NCT04154956) and phase 2 CARMEN-LC06 (NCT05245071) trials, which are evaluating the agent vs docetaxel in previously treated patients with CEACAM5-positive nonsquamous NSCLC

 and as a single agent in patients with negative or moderate CEACAM5 expression and high circulating carcinoembryonic antigen (CEA),

“CEACAM5 is a cellular antigen,” Spira said. “We’ve known about it for a long time. It’s expressed on many cancers, [including] lung cancer cells.”

, Spira discussed the rationale for targeting CEACAM5 in NSCLC, how tusamitamab ravtansine could provide encouraging frontline responses in the CEACAM5-positive, nonsquamous population, and enrollment challenges faced by these ongoing clinical trials.

Spira is the codirector of the Virginia Cancer Specialists Research Institute and the Phase I Trial Program in Fairfax. He is also co-chair of the USOncology Thoracic Oncology Committee, chair of the USOncology Research Executive Committee, and a member of the USOncology National Policy Board Executive Committee. In addition, Spira is an assistant professor of oncology at Johns Hopkins School of Medicine in Baltimore, Maryland.

: What makes CEACAM5 a novel target in lung cancer, and what is known about it?

: We believe it’s an adhesion molecule. It’s somewhat related to CEA, which is [typically tested for and measured] in the blood, although [it serves a different purpose in the current lung cancer research]. It’s unique because as a cellular target, you can guide drugs to it, specifically ADCs.

Is CEACAM5 easily detectable and prevalent in lung cancer?

It’s detectable on the cancer cells; it’s unfortunately not yet detectable in blood. Assays that are detectable on tissue are always more complicated to do. However, it’s easily detected based upon known assays, usually an immunohistochemistry assay.

You’re a principal investigator on the CARMEN-LC05 trial. What is this trial’s importance in the current treatment landscape?

CARMEN-LC05 is a straightforward study. It’s looking to see if the use of an ADC, tusamitamab ravtansine, can improve outcomes in patients with [nonsquamous NSCLC]. We’ve seen some impressive single-agent activity with tusamitamab ravtansine. The idea now is to see how good we can get the responses to be in the frontline setting and see if we can improve outcomes in patients positive for CEACAM5.

Tusamitamab ravtansine is also being studied in the CARMEN-LC03 and CARMEN-LC06 trials. What are some anticipated challenges with enrollment to these trials?

The big challenge that we have with enrollment, especially in the frontline setting but in all settings as well, is that patients need to have a positive CEACAM5 test to enroll. This is always a challenge because we’re trying to get that test back while [balancing other tasks] and getting the patient on the study.

It would be great if we had a blood test instead because we wouldn’t [face issues such as] needing to wait for tissue or running out of tissue. This is something that, with hard work, should be surmountable, although it’s proving more challenging [than we initially thought], until CEACAM5 [testing is done routinely]. However, that usually happens once the drug is commercially available, rather than in clinical trials.

Pending positive data from these trials, do you see these tusamitamab ravtansine regimens replacing current chemoimmunotherapy combinations or being sequenced after them?

There are first-line and second-line studies currently ongoing. We always like to do more in the frontline setting, because that’s when patients are healthier and [have better] long-term outcomes. That would be the ideal, but any improvement is always good. Certainly, the second-line treatment for NSCLC needs much improvement as well.

Could co-mutations influence other potential combination strategies?

Although co-mutations are important, this target is relatively unique right now. We’ll be looking at [factors such as] PD-L1 status. However, co-mutations are probably less important for this mutation, as it’s unique when compared with others such as 

What potential safety concerns can arise with ADCs like tusamitamab ravtansine?

ADCs have an antibody, a linker, and a warhead. As the warhead sometimes gets leaked into the blood because it doesn’t stay on perfectly well, [patients can have] cytopenias, nausea, and thrombocytopenia related to [their treatments]. [Additionally, we are] always worried about the gastrointestinal adverse effects, and many ADCs have some pulmonary toxicities. That all needs to be watched for in this patient population.

Tusamitamab ravtansine (SAR408701) in combination with pembrolizumab and tusamitamab ravtansine (SAR408701) in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed in patients with NSQ NSCLC (CARMEN-LC05) (CARMEN-LC05). ClinicalTrials.gov. Updated September 10, 2022. Accessed December 5, 2022. 

SAR408701 versus docetaxel in previously treated, carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) positive metastatic non-squamous non-small cell lung cancer patients (CARMEN-LC03). ClinicalTrials.gov. Updated November 4, 2022. Accessed December 5, 2022. 

https://www.clinicaltrials.gov/ct2/show/NCT04154956

Tusamitamab ravtansine in NSQ NSCLC participants with negative or moderate CEACAM5 expression tumors and high circulating CEA (CARMEN-LC06). ClinicalTrials.gov. Updated October 18, 2022. Accessed December 5, 2022. 

https://clinicaltrials.gov/ct2/show/NCT05245071

Alexander Spira, MD, PhD, FACP, discusses the rationale for targeting CEACAM5 in NSCLC, how tusamitamab ravtansine could provide encouraging frontline responses in the CEACAM5-positive, nonsquamous population, and enrollment challenges faced by ongoing clinical trials. 

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