ASCO 2024 Round-Up: Some Of The Most Impactful Cancer News Out Of The Big Meeting

seekingalpha06-06

AstraZeneca PLC showcased projects in two plenary lecture presentations at the Annual Meeting of the American Society of Clinical Oncology, or ASCO, including a trial that established osimertinib as ...

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The Big Meeting\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-06-06 21:07 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4697758-asco-2024-round-up-most-impactful-cancer-news-out-of-big-meeting><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>AstraZeneca PLC showcased projects in two plenary lecture presentations at the Annual Meeting of the American Society of Clinical Oncology, or ASCO, including a trial that established osimertinib as ...</p>\n\n<a href=\"https://seekingalpha.com/article/4697758-asco-2024-round-up-most-impactful-cancer-news-out-of-big-meeting\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0321505439.SGD","symbol_name":"Schroder ISF Global Dividend Maximiser A Acc 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surgery.Novartis' asciminib significantly improved the rate of major molecular response in patients with chronic myeloid leukemia.   picturegarden When I was preparing my article on the biotech companies to watch at this year's Annual Meeting of the American Society of Clinical Oncology, it was based on only the abstract titles and not much on the substance, just what we could glean from having different companies be present. In following up on this, I wanted to prepare a post-mortem highlighting some of the presentations with a likely substantial impact on the coming year in cancer care. Certainly, many articles on Seeking Alpha are going to offer individual takes on relatively narrow bits of information focused on specific companies. In this article, I want to give a rundown of some of the most impactful or surprising findings to come out of the meeting, at least in my opinion. This is not remotely a complete rundown of all the presentations of interest. I will be focusing mainly on the presentations I was looking forward to in the preview article, and giving some summary of how they shaped up. AstraZeneca Steals the Show AstraZeneca PLC (AZN) has been a dominating force of ASCO for years running, providing details of practice-changing findings, particularly within lung cancer. 2024 was no exception, as AZN showcased projects in 2 of the 5 plenary lecture presentations. LAURA was a randomized, phase 3 trial taking patients with stage III unresectable, EGFR-mutant NSCLC and giving them standard of care chemoradiation therapy, followed by either placebo or osimertinib. Osimertinib treatment led to a decisive progression-free survival benefit over placebo (median 39.1 vs 5.6 months), with a most notable ability to apparently prevent the development of brain metastases in this high-risk group of patients. This shifts the standard of care toward domination of osimertinib across nearly every disease stage for this EGFR-mutant population. The FLAURA and ADAURA trials have already established osimertinib as the standard of care in metastatic and operable cases, respectively. There are some questions about how long we truly need to be giving osimertinib (as highlighted by Dr. Sequist in the discussion, brain metastases appeared to be prevented only as long as osimertinib is continued, as evidenced by the ADAURA study). Also, osimertinib was associated with an increased risk of radiation pneumonitis, so there are considerations to balance, but overall this is a very positive result, continuing to support the use of osimertinib as a standard for EGFR-mutant NSCLC, now almost regardless of disease setting. ADRIATIC was the second AZN trial to be featured in the plenary session. Here, patients with limited stage small cell lung cancer received standard chemoradiation therapy, followed by either consolidation durvalumab, durvalumab plus tremelimumab, or placebo. This presentation only included finding for durvalumab vs placebo, showing that immune checkpoint blockade in this setting could improve median OS by 22 months (55.9 vs 33.4 months). This came at only a modestly increased risk of radiation pneumonitis. This puts durvalumab square in the sights as a standard of care for patients with limited stage SCLC, helping AZN continue to carve out this niche and distance itself from Roche's atezolizumab, which is approved (as is durvalumab) in combination with chemotherapy for extensive-stage (i.e., metastatic) small cell lung cancer. Bristol Myers Squibb Might Become More Dominant in Resectable Melanoma From an investor's standpoint, Bristol Myers Squibb Company (BMY) also had a critical presentation at the plenary lecture. Dr. Blank presented the first efficacy results from the NADINA trial, which is the first large, randomized study to assess whether it's better to give immunotherapy before surgery (neoadjuvant) compared with the standard of care, which is to reserve checkpoint inhibitors for after surgery (adjuvant). NADINA enrolled patients with stage III disease, and the long story made short was that giving nivolumab plus ipilimumab for 6 weeks before surgery led to a substantial reduction in the risk of melanoma returning after surgery. There are questions remaining about the censoring for the trial, but I think this is a clear path forward to get a first official approval for this strategy in this high-risk melanoma population. Moving some anti-PD-1 therapy to the neoadjuvant setting has already shown benefit for patients in this setting, so it seemed like a matter of time. However, this confirmation was extremely exciting, and I've seen various researchers on Twitter showing enthusiasm for neoadjuvant immunotherapy in other tumor settings. And realistically, it could allow BMY to stake a claim as the immunotherapy to use for resectable melanoma, building on other neoadjuvant experience they've seen with different combinations like nivolumab and relatlimab. From here, I want to turn our attention back to more disease-area focused studies. The plenary session seems to dominate the conversation year over year, but there are a lot of other things worth focusing on as well. Here's what caught my attention from ASCO 2024. Lung Cancer There were several significant threads in the lung cancer session, setting aside the general disappointment with Trop2-directed ADCs. First, a 5-year update of the CROWN study continues to suggest best-in-class activity for Pfizer's (PFE) ALK inhibitor lorlatinib, as overall survival continues to far outperform crizotinib, and the activity again tumors in the CNS continues to impress. There is controversy surrounding the use of crizotinib as a control, since second-generation ALK inhibitors have been standard treatment options for years, but this study continues to make a strong case for considering lorlatinib in the upfront setting for ALK-positive NSCLC. Another exciting study was PALOMA-3, which compared Amgen Inc.'s (AMGN) lazertinib plus either subcutaneous amivantamab or the approved intravenous formulation for patients with EGFR-positive NSCLC. The study established that the pharmacokinetics of amivantamab were similar between the 2 formulations. Meanwhile, there was a numeric advantage for subcutaneous amivantamab in terms of PFS (6.1 vs 4.3 months for subcu and IV, respectively). Surprisingly, there was a rather strong signal of overall survival benefit with subcu amivantamab, with 12-month overall survival rates of 65% and 51%, respectively. Meanwhile, infusion reaction risk was dramatically reduced with subcu amivantamab (13% vs 66%), while other rates of adverse events were similar between the two arms. Venous thrombotic events were also reduced with subcu amivantamab. These findings paint a clearly favorable picture for a future approval of subcutaneous amivantamab, and the combination looks like a strong candidate in the post-osimertinib disease relapse setting. Finally, the ivonescimab trial HARMONi-A has made a fairly significant, though controversial, splash for EGFR-mutated NSCLC. I actually covered this study (and Summit Therapeutics (SMMT)) in more detail in a recent article that I encourage you to check out if you are keen to learn more. A final abstract of note was out of NovoCure Limited's (NVCR) stable. They presented findings from the METIS study, showing that their tumor-treating fields could significantly prolong time to intracranial progression in patients who have NSCLC and brain metastases. This continues to affirm the increasingly clear benefit that tumor-treating fields can have in patients with cancers affecting the brain. Melanoma/Skin Cancers RELATIVITY-048 provided a look at the use of BMY's nivolumab plus ipilimumab plus relatlimab in patients with advanced melanoma, showing a confirmed response rate of 59%, and 4-year survival rate of 72%. These findings compare reasonably well with historical data on nivo-ipi and nivo-rela on their own, but we need larger studies to validate this benefit, considering the high rate of immune-related adverse events.  The Iovance Biotherapeutics, Inc. (IOVA) cell therapy lifileucel was also highlighted here, combining the treatment with pembrolizumab in checkpoint inhibitor-naive melanoma. The response rate to this combination was 65.2%, with 30.4% of patients achieving a complete response. The median duration of response was not reached after median follow-up of 21.7 months. This compares favorably with a benchmark ~33% response rate for pembrolizumab alone in this setting. IOVA is conducting a phase 3 trial, TILVANCE-301, to confirm these findings and possibly establish a new standard of care for metastatic melanoma. Building on my article about Moderna, Inc.'s (MRNA) neoantigen vaccine, the company had updated findings from their phase 2b study, with mRNA-4157 plus pembrolizumab showing a 49% reduction in recurrence-free survival and 62% reduction in distant metastasis compared with pembrolizumab alone. In all, 96% of patients remain alive in the study, giving a signal that mRNA-4157 could have a survival advantage over pembrolizumab, which would be a first. Per commentary on a company investor event to discuss these findings. one of the things that I've said about this technology overall for [individualized neoantigen therapy, INT] is that it really sits at this precipice and interface of technological advancement with next-generation sequencing and our understanding of cancer biology. And not only is that showcased in what we're achieving for INT, but it's also showcased with how we're designing our studies to learn about what INT can do and how we're sitting sort of at that peak of technological advancement. Hematologic Malignancies The biggest study coming out of ASCO for blood cancer was arguably presentation of ASC4FIRST, a phase 3 trial of Novartis AG's (NVS) next-generation Abl inhibitor asciminib versus other frontline TKIs in patients with CML. Asciminib significantly improved the rate of major molecular response at week 48, one of the co-primary endpoints of the study (67.7% vs 49.0%). Most of this was derived from improvement versus imatinib treatment, but there was a numerically higher rate of major molecular response for asciminib compared with second-generation TKIs, as well (66.0% vs 57.8%). Asciminib was also associated with lower rates of grade 3 or higher adverse events, particularly those AEs leading to treatment interruption or discontinuation. These findings suggest that asciminib could well be the frontline Abl inhibitor of choice for the future of CML management, and further follow-up will provide us more information on that front. In an investor event, the NVS Head of Oncology Jeff Legos had this to say in summary and comment: Scemblix had demonstrated superior efficacy with a favorable and safety tolerability profile. In particular, the data that we presented and highlighted demonstrated that Scemblix had superior major molecular response rates relative to the investigator selected TKIs and also relative to imatinib alone. ...And then lastly, in terms of our regulatory progress overall, we have actually completed the process or the package for the FDA submission. It is being reviewed under real time oncology review. And then lastly, we will continue our global submissions planned in the second half of 2024 and into 2025. The update of MANIFEST-2, focusing on MorphoSys AG's (MOR) pelabresib, continued to affirm the combo's ability to reduce the spleen size in patients with myelofibrosis, although symptom score reductions continue to not meet statistical significance. There is ongoing discussion about the limitations of symptom score assessment, and time will tell if failing to meet this endpoint will be a big problem for approval of pelabresib. I'm sanguine, personally, since key opinion leaders feel like the symptom score endpoint was a more regulatory add-on, and not necessarily one that tells us whether pelabresib has a real place in myelofibrosis management. Breast Cancer Eli Lilly and Company's (LLY) abemaciclib was the subject of the first late-breaker for the breast sessions. In postMONARCH, adding abemaciclib to fulvestrant was shown to improve progression-free survival compared with fulvestrant alone in patients with hormone-positive metastatic breast cancer and progression on prior treatment, including a CDK4/6 inhibitor. This is the first randomized indication that a continuing with CDK4/6 inhibition beyond progression can be a benefit for patients. In a late-breaking abstract, addition of pembrolizumab to sacituzumab govitecan did not improve progression-free survival in patients with hormone-positive advanced breast cancer following at least 1 prior line of endocrine therapy. However, there was a signal of benefit in patients who had PD-L1 positive tumors (median PFS, 11.1 vs 6.7 months), suggesting a way forward for this combination in future studies. Another big study of focus at the meeting was DESTINY-Breast06, which indicated that Daiichi Sankyo Company, Limited's (OTCPK:DSNKY) trastuzumab deruxtecan could improve median PFS over treatment of physician's choice in patients with metastatic HER2-low and -ultralow breast cancer. These patients had to have no prior chemotherapy, but they could have received endocrine therapy and/or CDK4/6 inhibitors. This marks what is likely going to be yet another label expansion for the blockbuster HER2 drug, and it adds more fuel to the fire that a well-designed antibody-drug conjugate can have activity even outside the context of high tumor expression of the antigen of interest. Developmental Therapies Novel ADCs were featured fairly prominently in this session, including entries from Merck (MRK), AbbVie (ABBV), and Shanghai Miracogen. The MRK entry, M9140, is a CEACAM5-directed ADC with an exatecan payload, which differs from Sanofi's terminated entry in the space. M9140 was studied here in patients with metastatic CRC, showing a disease control rate of 65% and 7.5% response rate among 40 patients. No ocular toxicities were noted, and tolerability was mainly limited to GI adverse events that were mild. There were quite a few other early projects covered in this session, but the KRAS inhibitors were a notable highlight. First was Lilly's KRAS G12C inhibitor olomorasib, a second-generation inhibitor. 184 patients were enrolled in their phase 1 study across a number of cohorts, mainly lung, colorectal, and pancreatic cancers. These included patients with prior exposure to a KRAS inhibitor. The drug was well tolerated, with no grade 4 or 5 adverse events. In non-CRC tumors, the response rate was 35%, indicating encouraging early activity for this agent. Olomorasib also had preliminary activity against brain metastases. The KRAS inhibitor developed by Jacobio Pharmaceuticals Group Co., Ltd. (OTCPK:JBPHF), glecirasib, was presented in combination with a SHP2 inhibitor. This presentation focused on updated safety and efficacy in frontline NSCLC with a KRAS G12C mutation. The confirmed response rate for this population was 64.7% across all dosage groups, suggesting substantial clinical activity for this combination. However, there was a high rate of grade 3/4 adverse events, occurring in 43.8% of these patients. This combination is now the subject of a phase 3 study comparing against chemo-IO for patients with metastatic NSCLC in China. Highlights in the immunotherapy developmental therapeutics session included a CAR-T cell therapy against Claudin-18.2, being developed by CARsgen Therapeutics Holdings Limited (OTCPK:CRTHF). In this group of patients with Claudin-18.2-positive GI cancers, almost everyone had grade 1 or 2 cytokine release syndromes, as well as high-grade adverse events related to the conditioning regimen. Across all treatment cohorts, the response rate was 38.8%, with 91.8% achieving disease control. For a distant reference, the Claudin antibody zolbetuximab plus chemotherapy in Claudin-positive gastric adenocarcinoma had a 53.8% response rate in the GLOW study. Another agent of interest is Regeneron's (REGN) bispecific antibody targeting EGFR and CD28 in combination with cemiplimab in patients with advanced solid tumors, with microsatellite stable CRC as a point of focus. Disease control was noted in this population, including one patient with liver metastases (which typically corresponds with poor outcomes). Colorectal Cancer One of my favorite studies from a few years ago (you may remember the reporting on it in newspapers) was the Memorial Sloan-Kettering Cancer Center experience using GSK plc's (GSK) dostarlimab in patients with locally advanced rectal cancer that has mismatch repair deficiency. 100% of the first handful of patients achieved a complete clinical response, and we've been waiting since then to see how the results shaped up. Dr. Cercek presented an update of this study as part of the rapid oral abstracts, showing that now there have been 42 patients treated in this setting, and all of them continue to have achieved complete remission. No patient to date has had a disease recurrence. It's incredibly interesting, to say the least, and it bodes well for a future role of dostarlimab in this setting, even though the results are from a single-arm trial. The potential to have surgery/chemo/radiation-free cure of this very specific form of rectal cancer is incredible. NEOPRISM-CRC operates on a similar premise, taking patients with mismatch repaired deficient, high-risk stage 2 or 3 colorectal cancer and giving neoadjuvant pembrolizumab. Another study of high importance was CheckMate 8HW, which enrolled patients with mismatch repair deficient metastatic colorectal cancer to receive chemotherapy, nivolumab, or nivolumab plus ipilimumab. Nivo-ipi is the only arm we have results for so far, and this yielded a 24-month PFS rate of 72%, compared with 14% for chemotherapy alone. We still need to see the results of the nivolumab-only arm to get a clearer picture of whether the combo is worth the toxicity in terms of benefit. A final colorectal cancer study worth touching on was ARC-9, looking at the Arcus Biosciences, Inc. (RCUS) drug etrumadenant in previously treated metastatic CRC. The combination of etrumadenant, zimberelimab, chemotherapy, and bevacizumab was shown to improve progression-free survival compared with regorafenib in patients with at most 2 prior lines of therapy in the metastatic setting (median PFS, 6.24 vs 2.07). The benefit was also present in patients who had baseline liver metastases, which I mentioned before is a feature predicting poor outcomes. So we're seeing an important theme continue to evolve, finding the right spots for immunotherapy in colorectal cancer. It's welcome news in a space that has always had many setbacks, particularly with immunotherapy to date. Other GI Tumors There were quite a few studies of medical interest, and smaller studies asking specific questions in tumors like cholangiocarcinoma and pancreatic cancer. However, nothing that really moved the needle toward drug approvals just yet. One particular abstract of interest was LBA4008, which detailed findings from CheckMate 9DW. This phase 3 study takes patients with unresectable liver cancer (specifically HCC) and randomizes them to standard TKI therapy (sorafenib or lenvatinib) or nivolumab plus ipilimumab, followed by nivolumab maintenance. Nivolumab-ipilimumab significantly improved overall survival for patients in this study, with medians of 23.7 and 20.6 for experimental and control arms, respectively. At 36 months, 38% of patients in the nivolumab-ipilimumab arm were still alive, compared with 24% for the standard of care arm. These findings suggest that the combo should be in the treatment option mix along with the TKIs, atezolizumab-bevacizumab (what many would argue is the real standard of care today), or the STRIDE regimen (single dose of tremelimumab followed by ongoing durvalumab). Head and Neck Cancer Anti-PD-1 therapies featured prominently in the head and neck session, with findings from DIPPER being presented as a late-breaking abstract. This study assessed the benefit of giving Elevar Therapeutics' camrelizumab (provided by Jiangsu Hengrui Pharmaceuticals) after chemoradiation therapy for nasopharyngeal carcinoma. Camrelizumab improved event-free survival with a hazard ratio of 0.56, though interestingly, it took until 12 months after randomization for the curves to start to separate. Camrelizumab also showed signs of preventing distant metastasis and locoregional relapse. Conclusion: Drinking from the fire hose This was far from a comprehensive roundup of the studies at ASCO, even if we just tried to focus on those that are practice-changing or -informing. Posters were a notable absence, and a lot of potentially hidden gems can be found there (every approved drug seems to start as a poster at ASCO at some point). Obviously, immunotherapy continues to play a dominant role in cancer medicine, and interest remains high here, explaining the various surges we've seen over the course of 2024 regarding novel approaches that are showing promise. Did you see anything that caught your attention at ASCO? I'd be happy to discuss in the comments section. Meanwhile, we're going to be picking apart these trial results for a long time to come, and it was definitely another successful year.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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