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Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

The FDA cleared cemiplimab-rwlc (Libtayo) for adjuvant use in adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. The decision was supported by findings from the phase 3 C-POST trial (NCT03969004), in which cemiplimab reduced the risk of recurrence or death by 68% vs placebo (HR, 0.32; 95% CI, 0.20-0.51; P < .0001), with median disease-free survival not reached in the cemiplimab arm. Recurrence occurred in 9% of patients in the cemiplimab arm vs 30% of those in the placebo arm. The toxicity profile was consistent with prior findings, with common adverse effects (AEs) including rash, pruritus, and hypothyroidism. The decision signifies the first and only immunotherapy approved for adjuvant treatment in those with CSCC with a high risk of recurrence following surgery and radiation.

The FDA has issued a complete response letter (CRL) to the new drug application (NDA) for dasatinib (Dasynoc) for use in patients with chronic myeloid leukemia (CML). The CRL stems from Good Manufacturing Practice observations at the company’s contract manufacturing site, prompting a temporary pause in new product approvals until corrective actions are completed. The manufacturer has begun remediation efforts and plans to meet with the regulatory agency later this year to address outstanding issues. The NDA for dasatinib sought approval for a formulation designed to maintain efficacy at lower doses, reduce pharmacokinetic variability, and minimize drug-drug interactions associated with acid-suppressive agents. Despite manufacturing delays, the drug remains under active development, with plans for expedited resubmission once compliance measures are met.

The regulatory agency also accepted and granted priority review to the biologics license application (BLA) seeking approval of Orca-T for select patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). The application is supported by data from the phase 3 Precision-T trial (NCT04013685), in which Orca-T significantly improved 1-year moderate-to-severe chronic graft-vs-host disease (cGVHD)–free survival vs conventional allogeneic hematopoietic stem cell transplant (allo-HSCT; 78% vs 38%; HR, 0.26; P < .00001). Those who received Orca-T also experienced lower rates of moderate-to-severe cGVHD (13% vs 44%) and grade 3/4 acute GVHD (6% vs 17%) vs allo-HSCT. One-year overall survival (OS) was 94% in the Orca-T arm and 83% in the allo-HSCT arm, and non-relapse mortality rates were 3% vs 13%, respectively. The target action date for the BLA is set for April 6, 2026.

Data from the phase 3 TROPION-Breast02 trial (NCT05374512) showed that datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) significantly improved OS and progression-free survival (PFS) vs investigator’s choice of chemotherapy in patients with locally recurrent, inoperable, or metastatic triple-negative breast cancer (TNBC) not able to receive immunotherapy. The safety profile of Dato-DXd was consistent with prior breast cancer studies. AstraZeneca and Daiichi Sankyo will share these results with regulatory authorities, highlighting the potential of the antibody-drug conjugate as the first therapy to significantly improve OS in this population.

The FDA has granted fast track designation to the TEAD autopalmitoylation inhibitor VT3989 for use in patients with unresectable malignant pleural or non-pleural mesothelioma who have progressed after previous immune checkpoint inhibition and platinum-based chemotherapy. Preliminary findings from an ongoing phase 1/2 trial (NCT04665206) demonstrated that the agent led to reductions in target lesion size in both pleural and non-pleural mesothelioma, irrespective of NF2 mutational status. The multicenter trial includes dose-escalation, dose-expansion, and combination cohorts, which are evaluating safety, antitumor activity, and pharmacokinetics of the agent, with oral dosing ranging from 25 mg to 200 mg. Common treatment-related AEs included albuminuria, proteinuria, fatigue, peripheral edema, and gastrointestinal and hepatic effects.

Honorable Mentions

• OncLive spoke with the following leading genitourinary oncology experts to highlight the most anticipated abstracts and data at the 2025 ESMO Congress: David A. Braun, MD, PhD, of Yale Medical School; Alan Tan, MD, of Vanderbilt University Medical Center; and Axel Merseburger, MD, PhD, of University Hospital Schleswig-Holstein. Check out the exclusive preview ahead of the meeting.
• From further clarifying the role of PD-(L)1 inhibition in gastric cancer and colorectal cancer, to demonstrating the potential predictive value of minimal residual disease negativity in late-stage colon cancer, gastrointestinal oncology data presented at the 2025 ESMO Congress are anticipated to challenge current standards of care and bring new questions to the forefront of research in the field. In this exclusive preview, Tanios S. Bekaii-Saab, MD, of Mayo Clinic; Suneel Kamath, MD, of Cleveland Clinic Lerner College of Medicine of Case Western Reserve University; and Kanwal P. S. Raghav, MBBS, MD, of The University of Texas MD Anderson Cancer Center, share their most anticipated abstracts.

As a leading venue for informed dialogue, the Weinberg Center commits itself to shaping and influencing corporate governance. In that spirit, I am delighted to discuss one of my top priorities as Chairman, which is to make being a public company an attractive proposition for more firms. Let’s face it: in many quarters and for many reasons, taking a company public is no longer so “cool” as it once was. There are approximately 4,700 exchange-listed companies today, compared to a high point of approximately 7,800 in 2007. My goal is to reverse this trend—to “Make IPOs Great Again” —and it involves three pillars. First, we must simplify and scale the SEC’s disclosure requirements to reduce the costs of preparing SEC filings and, at the same time, make them more comprehensible. Second, we must de-politicize shareholder meetings and return their focus to voting on director elections and significant corporate matters. Finally, we must reform the litigation landscape for securities lawsuits to eliminate frivolous complaints, while maintaining an avenue for shareholders to continue to bring meritorious claims. My remarks this evening will focus on the latter two pillars, each of which also implicates state corporate law.

1Based on information provided by Commission staff in the Division of Economic and Risk Analysis.(go back)

2For the past four proxy seasons, environment and social shareholder proposals represented 49% (2025), 60% (2024), 54% (2023), and 52% (2022) of all shareholder proposals voted at shareholder meetings. This data was provided by Proxy Analytics LLC. A proxy season refers to the period from July 1 of the prior year to June 30 of the stated year. Data is for companies included in the Russell 3000 Index.(go back)

3For the past four proxy seasons, environment and social shareholder proposals received, on average, 12.9% (2025), 16.2% (2024), 19.8% (2023), and 28.5% (2022) support. This compares to 23.2% (2025), 22.9% (2024), 23.5% (2023), and 32.4% (2022) support received for all shareholder proposals. This data was provided by Proxy Analytics LLC. A proxy season refers to the period from July 1 of the prior year to June 30 of the stated year. Data is for companies included in the Russell 3000 Index.(go back)

4In 2020, the Commission estimated that a company can incur up to $150,000 to process a shareholder proposal, and this amount does not include any opportunity costs associated with management’s time that could have been spent on value-creating activities for the company. See Procedural Requirements and Resubmission Thresholds under Exchange Act Rule 14a-8, Release No. 34-89964 (Sept. 23, 2020) [85 FR 70240, 70274 and note 295 (Nov. 4, 2020)].(go back)

517 CFR 240.14a-8.(go back)

6Procedural Requirements and Resubmission Thresholds under Exchange Act Rule 14a-8, Release No. 34-89964 (Sept. 23, 2020) [85 FR 70240, 70274 (Nov. 4, 2020)] (“[W]hile Rule 14a-8 provides a federal process for proxy voting and solicitation with respect to a shareholder proposal, matters of corporate organization such as voting rights and whether a proposal is a proper subject for action remain governed by state law.”) and Shareholder Proposals, Release No. 34-56160 (July 27, 2007) (the “2007 Long Proposing Release”) [72 FR 43466, 43467 (Aug. 3, 2007)] (“[T]he Commission has sought to use its authority in a manner that does not conflict with the primary role of the states …. For example, Rule 14a-8, the shareholder proposal rule, explicitly provides that a shareholder proposal is not required to be included in a company’s proxy materials if it ‘is not a proper subject for action by shareholders under the laws of the jurisdiction of the company’s organization.’”).(go back)

72007 Long Proposing Release at 43468 (“Because the proxy process is meant to serve, as nearly as possible, as a replacement for an actual, in-person meeting of shareholders, it should facilitate proposals concerning only those subjects that could properly be brought before a meeting under the corporation’s charter or bylaws and under state law.”).(go back)

8See Release No. 34-3347 (Dec. 18, 1942) [7 FR 10655 (Dec. 22, 1942)].(go back)

917 CFR 240.14a-8(i)(1).(go back)

10Id. See also Adoption of Amendments to Proxy Rules, Release No. 34-4979 (Jan. 6, 1954) (the “1954 Release”) [19 FR 246 (Jan. 14, 1954)]. The 1954 Release amended the predecessor to Rule 14a-8(i)(1) to “make it clear that State law is to be the standard of eligibility of a proposal under the rule.”(go back)

11Kyle Pinder, The Non-Binding Bind: Reframing Precatory Stockholder Proposals under Delaware Law, 15 Mich. Bus. & Entrepreneurial L. Rev. __ (forthcoming), available at https://papers.ssrn.com/sol3/Delivery.cfm/5418534.pdf?abstractid=5418534&mirid=1&type=2.(go back)

12See, e.g., Leo E. Strine Jr., Breaking the Corporate Governance Logjam in Washington: Some Constructive Thoughts on a Responsible Path Forward, 63 Bus. Law. 1079, 1088–1089 (2008) (“Strangely, precisely because state corporation laws do not contemplate non-binding stockholder votes on anything, the SEC has permitted non-binding or “precatory” proposals on virtually everything…As a result, stockholders had, by federal mandate, the option to require a stockholder referendum on a non-binding resolution when state law gives stockholders no right to demand such a show of hands.”) and Mohsen Manesh, The Corporate Contract and Private Ordering of Shareholder Proposals, 50 J. Corp. L. 1, 29 (2024) (“For one, there is nothing in Delaware’s statute or caselaw establishing as ‘settled’ public policy the right of shareholders to make or vote on a proposal at a shareholder meeting.”).(go back)

13Unofficial Transcript: Roundtable Discussions Regarding the Federal Proxy Rules and State Corporation Law (May 7, 2007) (“2007 Roundtable”) at 18, available at https://www.sec.gov/spotlight/proxyprocess/proxy-transcript050707.pdf. However, at the same roundtable, the late Frank Balotti, who I consider as one of the leading experts of Delaware corporate law, said that he believed precatory proposals were authorized by Section 211 of the Delaware General Corporation Law. Id. at 34 (“I think precatory resolutions are authorized by [Section] 211 [of the Delaware General Corporation Law], which says that a stockholder can bring before a meeting anything that is proper for a stockholder to act on. I believe that it is proper for stockholders to ask directors to do whatever, as opposed to telling directors to do whatever.”).(go back)

14Delaware Tells Companies: ‘Let’s Stay Together’, The Informed Board (Spring 2025), Edward B. Micheletti and Jenness E. Parker, available at https://www.skadden.com/insights/publications/2025/05/the-informed-board/delaware-tells-companies.(go back)

152007 Roundtable at 32 (“The question in 14a-8 land that we always deal with when we get shareholder proposals, one of the first basis to exclude it is it is inappropriate under state law. Whenever we get a precatory proposal, nobody ever argues to us that they don’t have authority to raise it under state law, which I find interesting…If in fact Delaware law doesn’t authorize precatory proposals, why do we not get that argument…?”).(go back)

16Id.(go back)

17Note 1 to Rule 14a-8(i)(1) states: “Depending on the subject matter, some proposals are not considered proper under state law if they would be binding on the company if approved by shareholders. In our experience, most proposals that are cast as recommendations or requests that the board of directors take specified action are proper under state law. Accordingly, we will assume that a proposal drafted as a recommendation or suggestion is proper unless the company demonstrates otherwise.”(go back)

18Amendments to Rules on Shareholder Proposals, Release No. 34-39093 (Sept. 18, 1997) [62 FR 50682, 50685 (Sept. 26, 1997)] (“We would revise the note to [paragraph (i)(1)] to reflect the Division [of Corporation Finance]’s current practice of assuming that a proposal drafted as a recommendation or request is proper unless the company demonstrates otherwise.”).(go back)

1917 CFR 24.14a-8(i)(1) note (“[W]e will assume that a proposal drafted as a recommendation or suggestion is proper unless the company demonstrates otherwise.”) (emphasis added).(go back)

20While the Commission amended the text of the note to its current form in 1998, the purpose of the amendment appears to have been to reflect the Division of Corporation Finance’s then practice of “assuming that a proposal drafted as a recommendation or request is proper unless the company demonstrates otherwise,” rather than no longer looking to state law to determine whether it is a “proper subject” based on the mandatory or precatory nature of the proposal. See supra note 18.(go back)

21Amendments to Rule 14a-8 Under the Securities Exchange Act of 1934 Relating to Proposals by Security Holders, Release No. 34-20091 (Aug. 16, 1983) [48 FR 38218, 38220 (Aug. 23, 1983)].(go back)

22A company is not required to obtain the staff’s views to exclude a proposal. These views are non-binding, and only a court can adjudicate whether a company can exclude a shareholder proposal submitted under Rule 14a-8 from its proxy statement. See Statement of Informal Procedures for The Rendering of Staff Advice With Respect to Shareholder Proposals, Release No. 34-12599 (July 7, 1976) [41 FR 29989 (July 20, 1976)]. If a company seeks the staff’s views to exclude a proposal, the company bears the burden of persuading the staff. 17 CFR 240.14a-8(g).(go back)

2317 CFR 240.14a-8(j)(2)(iii).(go back)

24DE Const. art. IV, § 11(8).(go back)

25CA, Inc. v. AFSCME Employees Pension Plan, 953 A.2d 227 (Del. 2008).(go back)

26Id. at 231.(go back)

27Id. at 229 (the court issued its opinion on July 17, 2008, following the Commission’s June 27, 2008 certification).(go back)

28See Paul S. Atkins, Shareholder Rights, the 2008 Proxy Season, and the Impact of Shareholder Activism (July 22, 2008) (“July 22, 2008 Speech”), available at https://www.sec.gov/news/speech/2008/spch072208psa.htm.(go back)

29Texas Senate Bill 1057, available at https://legiscan.com/TX/text/SB1057/2025.(go back)

30TX Bus. Orgs. § 21.373(e).(go back)

31See 17 CFR 240.14a-8(b)(1)(i).(go back)

32See, e.g., A New Era of Corporate Law in Texas, Latham & Watkins LLP (Sept. 23, 2025), available at https://www.lw.com/en/insights/a-new-era-of-corporate-law-in-texas and New Texas Law Applicable to “Nationally Listed Corporations” Sets Forth Heightened Requirements for Shareholder Proposals, Jackson Walker (Sept. 8, 2025), available at https://www.jw.com/news/insights-texas-law-shareholder-proposals/.(go back)

33Mark T. Uyeda, Remarks at the Society for Corporate Governance 2023 National Conference (June 21, 2023), available at https://www.sec.gov/newsroom/speeches-statements/uyeda-remarks-society-corporate-governance-conference-062123.(go back)

34Id. In a footnote to his remarks, Commissioner Uyeda addressed the 1947 decision by the Court of Appeals for the Third Circuit in SEC v. Transamerica Corporation et al., which could be interpreted as prohibiting a company from establishing its own standards for submitting shareholder proposal. Id. at note 55. I agree with Commissioner Uyeda’s views on this matter. For further discussion of Transamerica, see, e.g., Pinder, supra note 11, at 13-14.(go back)

35Hearings Before the Committee on Interstate and Foreign Commerce on H.R. 1493, H.R. 1821 and H.R. 2019, 78th Cong. 172 (1943) (“1943 Hearings”), at 172.(go back)

36Securities and Exchange Commission Agency Rule List – Spring 2025, available at https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST&currentPub=true&agencyCode=&showStage=active&agencyCd=3235.(go back)

37See e.g., Strine, supra note 12, at 1095 (“If investors seeking to change corporate governance really care about their proposals, why can’t they pay all of their own solicitation costs? Especially now that it is becoming both cheaper and easier to run an effective proxy contest because of the increase in institutional holdings and the ease of sending information electronically?”).(go back)

38Business Roundtable v. S.E.C., 905 F.2d 406 (D.C. Cir. 1990) (observing that “it is not seriously disputed that Congress’s central concern [when enacting the Exchange Act] was with disclosure” when holding that the Commission exceeded its statutory authority under the Exchange Act in adopting the one share, one vote rule barring exchanges and Nasdaq from listing common shares with unequal voting rights) and J.I. Case Co. v. Borak, 377 U.S. 426 (1964) (stating that “the purpose of Section 14(a) is to prevent management or others from obtaining authorization for corporate action by means of deceptive or inadequate disclosure in proxy solicitation.”).(go back)

39See 1943 Hearings at 163-165 (Congressman Boren raised concerns on shareholder proposals being misused by a few shareholder proponents using them as a platform to pursue their own propaganda), at 170-171 (Congressman Hall questioned why the management should be responsible for including proposals that it disagreed with), and at 175 (Congressman Reece criticized how the rule went beyond furnishing information).(go back)

40In my last formal speech to an outside group as a Commissioner in 2008, I raised some of the same issues regarding Rule 14a-8 and state corporate law as I do in these remarks. See July 22, 2008 Speech.(go back)

41See, e.g., Mohsen Manesh and Joseph A. Grundfest, The Corporate Contract and Shareholder Arbitration, 98 N.Y.U. L. Rev. 1106, 1110 (2023), available at: https://www.nyulawreview.org/wp-content/uploads/2023/10/98-NYU-L-Rev-1106.pdf.(go back)

42See Hal S. Scott & Leslie N. Silverman, Stockholder Adoption of Mandatory Individual Arbitration for Stockholder Disputes, 36 Harv. J. L. & Pub. Pol’y 1187, 1190 (2013), available at https://journals.law.harvard.edu/jlpp/wp-content/uploads/sites/90/2013/05/36_3_1187_Scott_Silverman.pdf.(go back)

43See, generally, Neil M. Gorsuch and Paul B. Matey, Settlements in Securities Fraud Class Actions: Improving Investor Protection, Andrews Class Action Litigation Reporter (Aug. 22, 2005).(go back)

44S.B. 95, 153rd Gen. Assemb. (Del. 2025), available at https://legis.delaware.gov/BillDetail/142081.(go back)

458 DEL. CODE ANN. Tit. 8, Section 115(c) (2025) (effective Aug. 1, 2025).(go back)

468 DEL. CODE ANN. Tit. 8, Section 102(f) & 109(b) (2025) (effective Aug. 1, 2025).(go back)

47See, generally, David H. Webber, Shareholder Litigation Without Class Actions, 57 Ariz. L. Rev. 201 (2015), available at https://scholarship.law.bu.edu/cgi/viewcontent.cgi?article=1035&context=faculty_scholarship, and Jens Dammann, Fee-Shifting Bylaws: An Empirical Analysis, The Journal of Law and Economics 65:1 (2022), available at: https://www.journals.uchicago.edu/doi/full/10.1086/718163.(go back)

48See, e.g., Scott, supra note 42 at 1209-1212 and Paul Weitzel, The End of Shareholder Litigation? Allowing Shareholders to Customize Enforcement Through Arbitration Provisions in Charters and Bylaws, 2013 BYU L. Rev. 65, 83 (2013), available at https://digitalcommons.law.byu.edu/lawreview/vol2013/iss1/2/.(go back)

49See, e.g., Jonathan T. Molot, Fee Shifting and the Free Market, 66 Vanderbilt Law Review 1807 (2013), available at https://scholarship.law.vanderbilt.edu/cgi/viewcontent.cgi?article=1322&context=vlr.(go back)

50Acceleration of Effectiveness of Registration Statements of Issuers with Certain Mandatory, Release No. 33-11389 (Sept. 17, 2025) [90 FR 45125 (Sept. 19, 2025)].(go back)

51Paul S. Atkins, Open Meeting Statement on Policy Statement Concerning Mandatory Arbitration and Amendments to Rule 431 of the Commission’s Rules of Practice (Sept. 17, 2025), available at https://www.sec.gov/newsroom/speeches-statements/atkins-091725-open-meeting-statement-policy-statement-concerning-mandatory-arbitration-amendments-rule-431.(go back)

52ATP Tour, Inc. v. Deutscher Tennis Bund, 91 A.3d 554 (Del. 2014).(go back)

53See Lee Rudy, Investors Opposing Fee-Shifting Bylaws (May 1, 2015), available at https://www.ktmc.com/news/investors-opposing-fee-shifting-bylaws.(go back)

54S.B. 75, 148th Gen. Assemb. (Del. 2015), available at https://legis.delaware.gov/BillDetail?LegislationId=24380.(go back)

55Synopsis, Senate Bill No. 75, available at https://legis.delaware.gov/BillDetail/24380.(go back)

56Stephen Bainbridge, Fee-Shifting: Delaware’s Self-Inflicted Wound, 40 Delaware Journal of Corporate Law 851, note 126 and accompanying text (2016), available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2624750.(go back)

57Paul Atkins, CA Has Hollywood, TX Has Oil, Delaware Corporation, RealClearMarkets (June 11, 2015), available at https://www.realclearmarkets.com/articles/2015/06/11/ca_has_hollywood_tx_has_oil_delaware_corporations.html.(go back)

58In 2024 and 2015, 67% and 66%, respectively, of Fortune 500 companies were incorporated in Delaware and 81% and 86%, respectively, of IPO issuers were incorporated in Delaware. See Delaware Division of Corporations: 2024 Annual Report, available at https://corpfiles.delaware.gov/Annual-Reports/Division-of-Corporations-2024-Annual-Report.pdf, and Delaware Division of Corporations: 2015 Annual Report, available at https://corpfiles.delaware.gov/Corporations_2015%20Annual%20Report.pdf.(go back)

59Jai Ramaswamy, Andy Hill, and Kevin McKinley, We’re Leaving Delaware, And We Think You Should Consider Leaving Too (July 9, 2025), available at https://a16z.com/were-leaving-delaware-and-we-think-you-should-consider-leaving-too/.(go back)

60Andrew D. Santana and Kacey Fonner, Stopping ‘Dexit’: Delaware Makes Significant Changes to Its General Corporation Law, Fox Rothschild (March 31, 2025), available at https://www.foxrothschild.com/publications/stopping-dexit-delaware-makes-significant-changes-to-its-general-corporation-law.(go back)

61S.B. 21, 153rd Gen. Assemb. (Del. 2025), available at https://legis.delaware.gov/BillDetail/141857.(go back)