ImmunoOncology

The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.  

Attendees at this year's European Society for Medical Oncology meeting in Barcelona can look forward to a range of interesting datasets, from Phase III trials of established products in new settings to preliminary studies of novel products coming through the pipeline.  

Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.

Recent ODACs suggest FDA is moving towards focusing not just on applications with pending approval decisions but on refining trials designs and drug labels for their competitors as well.

AstraZeneca’s NIAGARA trial of perioperative Imfinzi in bladder cancer was positively received at the ESMO meeting but its design did not distinguish the contributions of each treatment portion to the overall effect – something that the US FDA is likely to have a view on.    

Persistence has paid off for Incyte’s Zynyz in anal cancer with a Phase III win that should make up for a previous disappointment at the FDA and give a boost to the firm’s pipeline prospects for a post-Jakafi era.    

Even as US FDA expressed concern about the perioperative trial design, AstraZeneca’s ability to snag NSCLC indication without demonstrating the benefits of both the neoadjuvant and adjuvant phases of therapy highlights slow pace of agency policy shifts.

An option fee from potential program acquirer TuHura has enabled Kineta to resume enrolling a Phase I/II study of a VISTA-targeted antibody that the company thinks has best-in-class potential.

AstraZeneca is working to bolster its PD-L1 agent’s applicability in resectable non-small cell lung cancer, seeking advantages versus Merck’s Keytruda and Bristol’s Opdivo.

The company plans an end-of-Phase II meeting with the FDA for VP-315, for which it announced positive Phase II data indicating potential as a frontline treatment.

The drug maker is spending up to $1.3bn to acquire rights to CN201, a CD19xCD3-directed bispecific antibody that it plans to develop for B-cell malignancies and autoimmune diseases.

If closed successfully, the traditional producer of active pharmaceutical ingredients and generic drugs will scoop up the world’s second advanced KRAS G12D-targeting T-cell receptor (TCR) T cell therapy candidate, as well as an EGFR variant III-targeting chimeric antigen (CAR) receptor T-cell agent. Out-licensing efforts are already under way.

The Oncologic Drugs Advisory Committee urged the FDA not to delay Imfiniz’s perioperative NSCLC indication, while also unanimously pushing for better trial designs in lung cancer and all resectable tumors.

Big biopharma is struggling to find the next generation of cancer immunotherapies, but the sector’s smallest companies might just have the platforms of the future.

The agency wants sponsors to start with three core symptoms common across cancer therapeutics and then add more treatment-related adverse events from item libraries based on a drug’s mechanism of action and other factors.

The Oncologic Drugs Advisory Committee will vote on a product agnostic question related to perioperative trial designs during a 25 July meeting after discussing whether AstraZeneca needs an additional trial for its Imfinzi perioperative regimen in non-small cell lung cancer.

The German biotech has unveiled a $150m series D financing round to support a “broad Phase IIb development program for visugromab” and explore its potential to induce cancer remission depth and durability across multiple solid tumor indications.

After missing statistical significance in PD-L1+ head-and-neck cancer, Immutep presents data showing eftilagimod with Keytruda can offer efficacy in PD-L1-negative patients.

Grey Wolf Therapeutics has secured $99m via an expanded series B financing to advance its antigen modulation approach in cancer and to further explore its use in autoimmune disease indications.

It is not all over for Roche’s hopes for tiragolumab in frontline NSCLC but it may soon be.