This is a podcast about advancements in clinical trials as they emerge, before regulatory milestones or publication of associated data.
The views expressed are my own, and I have no financial affiliations with the companies discussed, nor is this affiliated with any employer.
Thank you all for your continued listenership after my hiatus! Microphone quality to be fixed for the next episode. If you have any questions, please reach out at inthepipelinepodcast@gmail.com or on Twitter/X @tdonatellov.
Sources:
Merck and Moderna Announce Phase 3 INTerpath-001 Trial of Intismeran Autogene Plus KEYTRUDA® Met Endpoints of Recurrence-Free Survival (RFS) and Distant Metastasis-Free Survival (DMFS) in Patients With Completely Resected Stage IIB-IV Melanoma (https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/)
Update on eVOLVE-Lung02 Phase III trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer (https://www.astrazeneca.com/media-centre/press-releases/2026/update-on-evolve-lung02-phase-iii-trial.html)
SANRECO Phase 2 Topline Results in Polycythemia Vera (https://s27.q4cdn.com/622061554/files/doc_events/2026/PH2-SANRECO-Results-Presentation_FINAL.pdf)
14 Apr 2026
Updates ON RAS with Daraxonrasib (3/23/26 - 4/13/26)
If you have any questions, please reach out at inthepipelinepodcast@gmail.com or on Twitter/X @tdonatellov. Thank you for listening!
Sources:
Daraxonrasib Demonstrates Unprecedented Overall Survival Benefit in Pivotal Phase 3 RASolute 302 Clinical Trial in Patients with Metastatic Pancreatic Cancer (https://ir.revmed.com/news-releases/news-release-details/daraxonrasib-demonstrates-unprecedented-overall-survival-benefit)
IDEAYA Biosciences and Servier Announce Positive Topline Results from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA-A*02:01-Negative Metastatic Uveal Melanoma (https://ir.ideayabio.com/2026-04-13-IDEAYA-Biosciences-and-Servier-Announce-Positive-Topline-Results-from-Phase-2-3-Registrational-Trial-OptimUM-02-of-Darovasertib-in-Combination-with-Crizotinib-in-First-line-HLA-A-02-01-Negative-Metastatic-Uveal-Melanoma)
Allogene Therapeutics Reports Interim Futility Analysis from Pivotal ALPHA3 Trial Showing 58.3% MRD Clearance with Cemacabtagene Ansegedleucel (Cema-Cel) vs. 16.7% in Observation Arm in First-Line Consolidation LBCL (https://ir.allogene.com/news-releases/news-release-details/allogene-therapeutics-reports-interim-futility-analysis-pivotal)
GSK presents positive data for B7-H4-targeted ADC in gynecological cancers (https://us.gsk.com/en-us/media/press-releases/gsk-presents-positive-data-for-b7-h4-targeted-adc-in-gynecological-cancers/)
Corrections:
Stated that there are >300 primary uveal melanona cases annually in the U.S., this figure is actually >3000 cases.
Did not mention that the OptimUM-02 trial of darovasertib + crizotinib included 437 patients randomized 2:1 to darovasertib + crizotinib or investigator's choice
24 Mar 2026
Varset-for-a Masked Approach (3/1/26-3/22/26)
If you have any questions, please reach out at inthepipelinepodcast@gmail.com or on Twitter/X @tdonatellov. Thank you for listening!
Topics:
CytomX’s Varsetatug Masetecan (EpCAM PROBODY® ADC) Continues to Demonstrate Positive Data Supporting Potential as a New Treatment Option in Late-Line Colorectal Cancer (https://ir.cytomx.com/news-releases/news-release-details/cytomxs-varsetatug-masetecan-epcam-probodyr-adc-continues)
Bristol Myers Squibb Announces Positive Phase 3 Results from the SUCCESSOR-2 Study of Oral Mezigdomide in Relapsed or Refractory Multiple Myeloma (https://news.bms.com/news/corporate-financial/2026/Bristol-Myers-Squibb-Announces-Positive-Phase-3-Results-from-the-SUCCESSOR-2-Study-of-Oral-Mezigdomide-in-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx)
Relmada Therapeutics Reports 12-Month Phase 2 Interim Data for NDV-01 in Non-Muscle Invasive Bladder Cancer (https://www.relmada.com/for-investors/news/detail/332/relmada-therapeutics-reports-12-month-phase-2-inte)
Genentech Provides Update on Phase III persevErA Study in ER-Positive Advanced Breast Cancer (https://www.gene.com/media/press-releases/15106/2026-03-08/genentech-provides-update-on-phase-iii-p)
Pfizer Announces Positive Topline Phase 2 Results for Next-Generation CDK4 Inhibitor, Atirmociclib, in Second-Line Metastatic Breast Cancer (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-2-results-next)
6 Jan 2026
Important lidERAbilities (11/30/25-1/4/26)
If you have any questions, please reach out at inthepipelinepodcast@gmail.com or on Twitter/X @tdonatellov. Thank you for listening!
Topics:
Ph III (lidERA) giredestrant in adjuvant ER+/HER2-negative, early BC (https://assets.roche.com/f/176343/x/55a0097f19/final_20251211_sabcs-roche-s-virtual-oncology-investor-event.pdf)
TERN-701 CARDINAL Trial December 2025 Data Update (https://ir.ternspharma.com/static-files/a03e11d3-7967-4087-b273-0a871873d43d)
JANX007 Phase 1 Clinical Update (https://s201.q4cdn.com/681340001/files/doc_presentations/2025/Dec/01/JANUX-NC-JANX007-PU-DECK-FINAL-12012025.pdf)
2 Dec 2025
Time to be bASHful (11/16-11/29)
If you have any questions, please reach out at inthepipelinepodcast@gmail.com. Thank you for listening!
Topics:
Sonrotoclax (BGB-11417) monotherapy in patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) previously treated with a bruton tyrosine kinase (BTK) inhibitor: Early results from A phase 1/2 study (https://meetings-api.hematology.org/api/abstract/vmpreview/296316)
Primary results from VAYHIT2, a randomized, double-blind, phase 3 trial of ianalumab plus eltrombopag versus placebo plus eltrombopag in patients with primary immune thrombocytopenia (ITP) who failed first-line corticosteroid treatment (https://meetings-api.hematology.org/api/abstract/vmpreview/304584)
Minimal residual disease (MRD)-negative outcomes following a novel, in vivo gene therapy generating anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells in patients with relapsed and refractory multiple myeloma (RRMM): Preliminary results from inMMyCAR, the first-in-human phase 1 study of KLN-1010 (https://meetings-api.hematology.org/api/abstract/vmpreview/304572)
21 Nov 2025
Best in BezuCLAStinib (11/2-11/15)
If you have any questions, please reach out at inthepipelinepodcast@gmail.com. Thank you for listening!
Topics:
Cogent Biosciences Reports Positive Results from Bezuclastinib PEAK Phase 3 Trial in Gastrointestinal Stromal Tumors (GIST) (https://investors.cogentbio.com/news-releases/news-release-details/cogent-biosciences-reports-positive-results-bezuclastinib-peak)
Detalimogene Demonstrates Improved Complete Response Rate of 62% at 6 Months (https://engene.com/detalimogene-demonstrates-improved-complete-response-rate-of-62-at-6-months/)
Relmada Announces FDA Feedback Supporting 2 Separate Acceptable Registrational Study Paths for NDV-01 in Non-muscle Invasive Bladder Cancer (https://www.relmada.com/for-investors/news/detail/326/relmada-announces-fda-feedback-supporting-2-separate)
Update on Amgen’s bemarituzumab Phase 1b/3 FORTITUDE-102 Study (https://zailab.gcs-web.com/news-releases/news-release-details/update-amgens-bemarituzumab-phase-1b3-fortitude-102-study)
5 Nov 2025
Epigenetic Bonanza (10/19-11/1)
The first episode of the relaunched podcast, focusing exclusively on oncology/hematology.
If you have any questions, please reach out at inthepipelinepodcast@gmail.com. Thank you for listening!
Topics:
Tango Therapeutics Reports Positive Data from Ongoing Phase 1/2 Study with Vopimetostat (TNG462) in Patients with MTAP-deleted Cancers (https://ir.tangotx.com/news-releases/news-release-details/tango-therapeutics-reports-positive-data-ongoing-phase-12-study)
Halda Therapeutics Announces First-in-Human Results for HLD-0915, an Oral RIPTAC™ Therapeutic Demonstrating Encouraging Safety and Anti-Tumor Activity in Metastatic Castration-Resistance Prostate Cancer (mCRPC) (https://haldatx.com/halda-therapeutics-announces-first-in-human-results-for-hld-0915-an-oral-riptac-therapeutic-demonstrating-encouraging-safety-and-anti-tumor-activity-in-metastatic-castration-resistance-prost/)
10 Aug 2025
Episode 1 - July 2025
Thank you for checking out the first episode of the podcast! If you have any questions or corrections you would like for me to address you can reach me in the following ways:
Email: inthepipelinepodcast@gmail.com
Twitter/X: tdonatellov
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