T cell therapy | Leaders in Pharmaceutical Business Intelligence Group, LLC, Doing Business As LPBI Group, Newton, MA

Posts Tagged ‘T cell therapy’

Immune-Oncology Molecules In Development & Articles on Topic in @pharmaceuticalintelligence.com

Posted in Cancer and Current Therapeutics, CANCER BIOLOGY & Innovations in Cancer Therapy, CAR-T, combination immunotherapies., Efficacy of Anti-Tumor T Cells, Immune Modulatory, Immunotherapy, Modulating Macrophages in Cancer Immunotherapy, NK Cell-Based Cancer Immunotherapy, tagged adoptive T cell, checkpoint inhibitor, genetically modified immune cells, T cell therapy, TILs on January 11, 2016| Leave a Comment »

Immune-Oncology Molecules In Development & Articles on Topic in @pharmaceuticalintelligence.com

Curators: Stephen J Williams, PhD and Aviva Lev-Ari, PhD, RN

UPDATED on 06/16/2026

Since 2020, the FDA has significantly expanded the immuno-oncology (IO) landscape, approving several novel agents and expanding existing immunotherapies (e.g., checkpoint inhibitors, CAR-T, bispecific antibodies) for early-stage and metastatic solid and hematologic tumors.

Major novel immuno-oncology drugs and foundational indication expansions include:

1. Novel Bispecific Antibodies & T-Cell Engagers (BiTEs)

- Tarlatamab-dlle {Imdelltra}: Approved in 2024 for extensive-stage small cell lung cancer (SCLC) that has progressed on or after platinum-based chemotherapy.
- Epcoritamab {Epkinly}: Approved in 2023-2024 for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL).
- Teclistamab {Tecvayli}: Approved in 2022 as the first bispecific T-cell engager for heavily pretreated relapsed or refractory multiple myeloma.

2. Dual Checkpoint Inhibition & Novel Combinations

- Nivolumab + Relatlimab {Opdualag}: Approved in 2022, introducing a first-in-class dual checkpoint inhibitor combination (LAG-3 and PD-1 blockade) for advanced melanoma. [1, 2, 3, 4]
- Pembrolizumab {Keytruda}+ Enfortumab Vedotin {Padcev} Approved for previously untreated, locally advanced, or metastatic urothelial cancer, redefining first-line therapy. [1]
- Durvalumab {Imfinzi}: Saw significant label expansions, including perioperative use in early-stage non-small cell lung cancer (NSCLC) and for biliary tract cancer. [1]

3. Cellular Therapies (CAR-T)

- Lisocabtagene maraleucel {Breyanzi}: A CD19-directed CAR-T cell therapy approved in 2021 for relapsed or refractory large B-cell lymphoma, and later expanded.
- Ciltacabtagene autoleucel{Carvykti}: Approved in 2022 for relapsed or refractory multiple myeloma. [1, 2, 3, 4, 5]

4. Cytokine Therapies & New Formulations

Subcutaneous Immunotherapies: The FDA approved faster, subcutaneous (under the skin) injection formulations of established blockbusters, such as Tecentriq Hybreza (atezolizumab and hyaluronidase) and Darzalex Faspro (daratumumab and hyaluronidase)

5. New NON CART cellular therapies

modified infiltrating Tumor Lymphocytes Lifileucel (please see post https://pharmaceuticalintelligence.com/2026/06/12/tumor-infiltrating-lymphocytes-til-as-a-first-of-kind-fda-approved-immunotherapy-for-cancer/

👑 𝗔𝗳𝘁𝗲𝗿 𝗞𝗲𝘆𝘁𝗿𝘂𝗱𝗮: 𝗪𝗵𝗲𝗿𝗲 𝗜𝘀 𝗠𝗲𝗿𝗰𝗸’𝘀 𝗡𝗲𝘅𝘁 𝗞𝗶𝗻𝗴?

Everyone talks about what comes after Keytruda.

Let’s see if Merck‘s acquisition history offers some clues!

Looking at 32 acquisitions over the past 20 years, one thing stands out:
It is not what Merck bought.
It is what Merck did NOT buy!

Despite Keytruda becoming one of the most successful oncology drugs in history, Merck has not made a major acquisition in several of the hottest post-Keytruda modalities:
• CAR-T
• T-cell engagers
• Radiopharmaceuticals
• Cell therapies

Instead, the company’s oncology acquisitions have largely focused on:
• Small molecules
• ADCs
• Cancer vaccines
• Immune-modulating platforms

Deals such as VelosBio, Tilos, Viralytics, Rigontec, Immune Design, and more recently, Terns Pharmaceuticals and Modifi Bio, expanded Merck’s oncology pipeline but were not obvious “next Keytruda” bets.

At the same time, Merck deployed significant capital outside oncology:
• Acceleron → Cardiovascular
• Prometheus → Immunology
• Verona → Pulmonology
• Cidara → Infectious Diseases

The acquisition record suggests a different strategy.
Rather than betting on a single successor to Keytruda, Merck appears to be building multiple future growth pillars across therapeutic areas and technologies.

Perhaps the real question is not:
“What will replace Keytruda?”
But:
“Does Merck even want a single replacement?”

UPDATED on 10/2/2018

2018 Nobel Prize in Physiology or Medicine for contributions to Cancer Immunotherapy to James P. Allison, Ph.D., of the University of Texas, M.D. Anderson Cancer Center, Houston, Texas. Dr. Allison shares the prize with Tasuku Honjo, M.D., Ph.D.,of Kyoto University Institute, Japan

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2018/10/01/2018-nobel-prize-in-physiology-or-medicine-for-contributions-to-cancer-immunotherapy-to-james-p-allison-ph-d-of-the-university-of-texas-m-d-anderson-cancer-center-houston-texas-dr-allison-sh/

UPDATED on 9/5/2017

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/08/30/fda-has-approved-the-worlds-first-car-t-therapy-novartis-for-kymriah-tisagenlecleucel-and-gileads-12-billion-buy-of-kite-pharma-no-approved-drug-and-canakinumab-for-lung-cancer-may-be/

Novartis’ Kymriah (tisagenlecleucel), FDA approved genetically engineered immune cells, would charge $475,000 per patient, will use Programs that Payers will pay only for Responding Patients

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2017/08/31/novartis-kymriah-tisagenlecleucel-fda-approved-genetically-engineered-immune-cells-would-charge-475000-per-patient-will-use-programs-that-payers-will-pay-only-for-responding-patients/

UPDATED on 9/27/2016

Kite Pharma ($KITE) climbs after Phase II data tee up FDA filing for CAR-T

Kite Pharma ($KITE) has posted an interim analysis of Phase II CAR-T data it thinks are strong enough to support regulatory approval. The CAR-T triggered complete remissions in 47% of patients with an aggressive form of non-Hodgkin lymphoma (NHL), although a dropoff in the number of responders over the first three months has raised questions about durability.

At the time of the interim analysis, Kite had administered its CD19-targeting CAR-T to 51 patients with chemorefractory diffuse large B-cell lymphoma (DLBCL). More than three quarters of patients experienced an objective response. Close to half experienced complete remission. When paired to stronger data from a small group of patients with transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL), Kite thinks the interim analysis boosts its prospects.

http://www.fiercebiotech.com/biotech/kite-climbs-after-phii-data-tee-up-fda-filing-for-car-t?utm_medium=nl&utm_source=internal&mrkid=993697&mkt_tok=eyJpIjoiTURRM1pXWmpNVFZtTjJFMyIsInQiOiJmUmp3NlJKbVluZFYxWHQrQkxyblR6Njh3Q3lSa0dFVVRcL3pzdmNrZERPa091QWp2OXBWNnBwc1NnMWJqSDNjbHRUNTFDZnl3QWxQQUxubUNoQnlwNmNJengwOE9wUXNZSUNjT00yenNsY2s9In0%3D

UPDATED on 9/27/2016

Amgen Announces Top-Line Results From Phase 3 KYPROLIS® (Carfilzomib) CLARION Study In Newly Diagnosed Multiple Myeloma Patients

Amgen to Hold Analyst Call Today at 8:30 a.m. ET

THOUSAND OAKS, Calif., Sept. 27, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of KYPROLIS^® (carfilzomib), melphalan and prednisone (KMP) versus Velcade^® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 – 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 – 1.64). Neither result was statistically significant.

Overall, the adverse events in the KMP arm were consistent with the known safety profile of KYPROLIS. The incidence of Grade 3 or higher adverse events was 74.7 percent in the KMP arm and 76.2 percent in the VMP arm. Fatal treatment-emergent adverse events occurred in 6.5 percent of KMP patients and 4.3 percent of VMP patients. The incidence of Grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5 percent in the KMP arm and 35.1 percent in the VMP arm.

http://www.amgen.com/media/news-releases/2016/09/amgen-announces-topline-results-from-phase-3-kyprolis-carfilzomib-clarion-study-in-newly-diagnosed-multiple-myeloma-patients/

UPDATED on 6/8/2016

Cancer researchers see promise in giving patients combinations of multiple drugs that are proving more effective than one or two. But the strategy poses a dilemma for health insurers and patients: even higher prices.