Novartis announces tislelizumab helped extend median overall survival in first-line advanced esophageal cancer 

Novartis (NYSE:NVS) has announced that chemotherapy plus tislelizumab, a humanized monoclonal antibody directed against PD-1, improved overall survival as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the Phase 3 RATIONALE 306 study.

The survival benefits were seen in patients regardless of PD-L1 status.

The benefits were consistent across patient subgroups in the study.

In the study, the combination of tislelizumab and chemotherapy resulted in median overall survival of 17.2 months compared to 10.6 months in patients receiving chemotherapy plus placebo.

Investigators concluded that the combination of chemotherapy and tislelizumab cut the risk of death by 34%.

Tislelizumab was first developed by BeiGene. Novartis paid $650 million for rights to the drug. The company also stands to pay up to $1.55 billion in potential milestone payments.

Novarti…

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FDA approves new Opdivo indications for upper gastroesophageal cancers

Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).

The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC.

Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.

First FDA approved in 2014 for advanced melanoma, Opdivo has won a score of oncology indications over the years.

The drug now has five indications covering upper gastroesophageal cancers.

The two recent approvals are based on data from the Phase 3 CheckMate -648 trial, which Bristol Myers Squibb notes is the largest Phase 3 trial of an immunotherapy in first-line ESCC. In that study, Opdivo with chemotherapy offered a superior overall survival rate than chemotherapy alone.

Opdivo with Yervoy also led to improved survivability…

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Janssen EMEA gets conditional marketing authorisation for Rybrevant in NSCLC patients

Janssen (NYSE:JNJ) has received European authorisation for Rybrevant (amivantamab-vmjw) to treat adults with non-small cell lung cancer (NSCL) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Rybrevant is a fully-human EGFR-MET bispecific antibody.

NSCL is responsible for the majority of lung cancers.

The Conditional Marketing Authorisation (CMA) covers patients who have failed platinum-based chemotherapy.

Amivantamab is the first treatment to win approval in the EU specific to EGFR exon 20 insertion mutations for NSCLC. “Patients with NSCLC harboring EGFR exon 20 insertion mutations represent a specific population who have been underserved by current treatment options that are limited in both number and efficacy,” said Dr. Antonio Passaro, Medical Oncologist at the Division of Thoracic Oncology of the European Institute of Oncology, in a press release.

Clinical trials for amivantamab are underway for sol…

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AstraZeneca’s Imfinzi and tremelimumab show promise in non-small cell lung cancer study

AstraZeneca (LON: AZN) announced that Imfinzi (durvalumab) together with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The data came from a Phase 3 trial known as POSEIDON.

Imfinzi and tremelimumab are immune checkpoint inhibitors.

“The POSEIDON data offer patients further benefit from Imfinzi and are an important validation of our development strategy to explore novel combinations,” said Susan Galbraith, AstraZeneca’s executive vice president, oncology R&D.

Imfinzi is a human monoclonal antibody that targets programmed death-ligand 1 (PD-L1).

While many Big Pharma firms have developed PD-L1 drugs, few have become blockbusters — Bristol Myers Squibb’s Yervoy (ipilimumab) is one exception.

The POSEIDON trial had 338 recipients who received Imfinzi, tremelimuma…

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