How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

On Jan. 9, Pierre Fabre Pharmaceuticals received a “complete response letter” from FDA: its application for the T-cell therapy tabelecleucel (Ebvallo) was getting a hard No.

Phase III persevERA study of giredestrant combination in ER-positive advanced breast cancer does not meet primary objective

The phase III persevERA Breast Cancer study, evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed.

March 13, 2026

Vol.52 No.10

Clinical Roundup

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, according to positive interim phase III results from the SUCCESSOR-2 study.

March 13, 2026

Vol.52 No.10

Clinical Roundup

Nutrition therapy extends survival by 34% in stage 4 pancreatic cancer patients, clinical trial shows

Medically supervised, individualized nutrition therapy—long proven effective in reversing metabolic diseases like type 2 diabetes and obesity—shows promise in extending survival in patients with metastatic pancreatic cancer when used alongside chemotherapy, according to data from a randomized, controlled phase II clinical trial.

March 13, 2026

Vol.52 No.10

Clinical Roundup

Phase I data released from study of Lymphir dosing prior to commercial CAR T therapy in high‑risk diffuse large b‑cell lymphoma

Citius Oncology announced positive topline safety and efficacy results from an investigator‑initiated phase I trial evaluating Lymphir (E7777, denileukin diftitox‑cxdl) administered prior to commercial CD19‑directed CAR T therapy in patients with high‑risk relapsed or refractory diffuse large B‑cell lymphoma.

March 13, 2026

Vol.52 No.10

Clinical Roundup

Positive topline results announced from phase I study of Lymphir + pembrolizumab in r/r gynecologic cancers

Citius Oncology announced positive topline results from a completed investigator‑initiated phase I clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory cell depletion activity of Lymphir (denileukin diftitox‑cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (Keytruda) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies.

March 13, 2026

Vol.52 No.10

How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

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Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

Phase III persevERA study of giredestrant combination in ER-positive advanced breast cancer does not meet primary objective

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Nutrition therapy extends survival by 34% in stage 4 pancreatic cancer patients, clinical trial shows

Phase I data released from study of Lymphir dosing prior to commercial CAR T therapy in high‑risk diffuse large b‑cell lymphoma

Positive topline results announced from phase I study of Lymphir + pembrolizumab in r/r gynecologic cancers

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How to navigate early clinical development and support robust registrational strategy and late-stage development in oncology

YOU MAY BE INTERESTED IN

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”

Phase III persevERA study of giredestrant combination in ER-positive advanced breast cancer does not meet primary objective

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Nutrition therapy extends survival by 34% in stage 4 pancreatic cancer patients, clinical trial shows

Phase I data released from study of Lymphir dosing prior to commercial CAR T therapy in high‑risk diffuse large b‑cell lymphoma

Positive topline results announced from phase I study of Lymphir + pembrolizumab in r/r gynecologic cancers

Never miss an issue!

Login

Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncology
Atara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.”