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new lung cancer treatment breakthrough 2021 :: Article Creator

'Amazing' New Lung Cancer Treatment 40% More Effective Than Standard Amid 'golden Age' Of Cancer Research

A new drug combo recently approved by the Food & Drug Administration can halt lung cancer in its treacherous tracks — for over 40% longer than previously possible, a wide-ranging trial funded by pharmaceutical giant Janssen showed.

Doctors are hailing the breakthrough as "amazing."

Lung cancer kills roughly 1.8 million people per year. The insidious disease is known for very low survival rates, particularly in those in advanced stages.

A new drug combo can stop lung cancer in its tracks for longer, a new trial showed. Chinnapong – stock.Adobe.Com Lung cancer kills nearly two million people per year. The new treatment stopped the disease from advancing for an average of about two years. Mark Kostich – stock.Adobe.Com

The Guardian reported that a group of patients in that precarious state were given a cocktail of amivantamab, a monoclonal antibody, and lazertinib, a tyrosine kinase inhibitor — keeping them alive and progression-free for an average of 23.7 months.

Sufferers who received the standard treatment, a drug called osimertinib, averaged 16.6 months of progression-free survival, the outlet revealed.

The findings come as experts reportedly hail a "golden age" of cancer research that is leading to better comprehension and better treatment methods.

"It's amazing to see this new combination shows longer cancer control than osimertinib, which was itself a breakthrough treatment only a few years ago," said Martin Forster, the UK trial chief and a medical oncologist at University College Hospital, said.

"Better understanding of the biology that drives lung cancers has guided the development of these targeted therapies," Forster explained.

The findings come amid what is being referred to as a "golden age" of cancer research. Dragana Gordic – stock.Adobe.Com

More than 1,000 patients were enrolled in the phase 3 trial, conducted during 2020-2022 in multiple countries.

All were in the advanced stages of the common non-small cell lung cancer, or NSCLC.

They were randomly assigned to either the drug combo or the standard treatment the group of patients would have all have normally received.

"By combining these two drugs, which stop the cancer from growing in different ways, we see a significant improvement in progression-free survival rates compared to the drug we currently use," said Raffaele Califano, a consultant in medical oncology involved with the trail.

"Survival rates for lung cancer are still very low compared with other types of the disease and so to see such positive results is a welcome development."

"We are in a golden age of cancer research where a greater understanding of what drives specific cancers is informing new and better ways to beat the disease," Anna Kinsella of Cancer Research UK told The Guardian.

"Research like this helps more people to live longer, better lives, free from the fear of cancer."

The FDA gave the go-ahead to the treatment in August.

The Post previously reported that researchers are campaigning to ban cigarette sales to Gen Z smokers — saying that the move would save 1.2 million lives normally lost to lung cancer, over a period of 70 years.


FDA Gives AbbVie's C-Met Lung Cancer ADC A Breakthrough Tag

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status.

Teliso-V (telisotuzumab vedotin) is pitching to become the first targeted cancer treatment for people with non-small cell lung cancer (NSCLC) whose tumours overexpress c-Met.

The c-Met protein thought to be both a driver of cancer itself, as well as a resistance mechanism that tumours can develop to protect them from some widely-used NSCLC therapies, including EGFR inhibitors.

Teliso-V is currently in a 233-patient phase 2 study (LUMINOSITY) involving subjects with c-Met-positive, non-squamous NSCLC as a second- or third-line treatment after chemotherapy, immunotherapy with checkpoint inhibitors or drugs targeted at specific mutations.

Preliminary results from that study showed a 53.8% overall response rate (ORR) in patients with high levels of c-Met expression, and 25% in those with intermediate levels, showing proof of concept for the ADC.

The FDA reserves breakthrough therapy status for therapies that could represent a significant improvement over standard of care – in this case platinum-based chemotherapy – in either efficacy, safety, or both.

Excluded from that study are patients with EGFR mutations, and AbbVie is looking specifically at this group in a phase 1 study that is looking at the combination of Teliso-V and AstraZeneca's EGFR inhibitor Tagrisso (osimertinib), to see if the ADC can boost efficacy and potentially reduce the risk of resistance developing.

A phase 3 trial – called TeliMET-NSCLC-01 – is also due to start in the coming months that will compare Teliso-V to docetaxel chemotherapy in c-Met-positive, non-squamous NSCLC, in patients both with and without other gene mutations including EGFR and ALK.

Other drugmakers have been looking at Met as a target in cancer, including Novartis, Merck KGaA and Hutchmed, which have all bagged regulatory approvals for oral therapies that target NSCLC harbouring a specific mutation in Met known as exon 14 skipping  which affects about 3% to 4% of NSCLC patients.

Merck's Tepmetko (tepotinib) was approved by the FDA last year for both treatment naïve and previously treated METex14 positive NSCLC patients, as was Novartis' Tabrecta (capmatinib), while Hutchmed's Orpathys (savolitinib) has been approved as a second-line option in China.

Hutchmed's drug is also being paired with Tagrisso and AZ's PD-L1 blocker Imfinzi (durvalumab) in global registrational trials.


FDA Fast-Tracks AbbVie's New Lung Cancer Therapy Emrelis For Tough Lung Cancer Cases

The U.S. Food and Drug Administration (FDA) granted accelerated approval to AbbVie Inc.'s ABBV Emrelis (telisotuzumab vedotin-tllv) for adult patients with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression (OE) who have received a prior systemic therapy.

High c-Met protein overexpression is defined as ≥ 50% of tumor cells with strong (3+) staining as determined by an FDA-approved test.

This indication is approved based on overall response rate (ORR) and duration of response (DOR).

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s), the company said in a statement on Wednesday.

Also Read: AbbVie Scores FDA Approval For Its Blockbuster Drug Rinvoq To Treat Type Of Arthritis

Emrelis is a c-Met-directed antibody-drug conjugate (ADC) and the first and only treatment approved for this patient population. 

ADCs are designed to target unique biomarkers such as the c-Met protein and deliver a potent 'payload' directly to the biomarker-expressing cell.

Data from the Phase 2 LUMINOSITY study, designed to characterize the efficacy and safety of EMRELIS in c-Met overexpressing advanced NSCLC populations, support the FDA's accelerated approval.

Findings from the study showed patients with high c-Met protein overexpression (n=84) who received Emrelis demonstrated a 35% Overall Response Rate (ORR) and Duration of Response (DOR) with a median of 7.2 months.

In December 2021, the FDA granted EMRELIS Breakthrough Therapy Designation (BTD) based on Phase 2 LUMINOSITY study data.

Emrelis is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01.

Enrollment in the study is underway and continues across global clinical trial sites.

The FDA has also approved Roche Holdings AG's RHHBY VENTANA MET (SP44) RxDx Assay, the only IHC companion diagnostic identifying patients eligible for Emrelis treatment.

On Wednesday, AbbVie and ADARx Pharmaceuticals announced a collaboration and license option agreement to develop small interfering RNA (siRNA) therapeutics across multiple disease areas, including neuroscience, immunology, and oncology.

siRNA represents a class of molecules capable of regulating gene expression and protein production. Unlike traditional modalities such as antibodies and small molecules, siRNA regulates gene expression. These molecules are designed to prevent the production of disease-causing proteins by targeting the messenger RNA (mRNA) that encodes for such proteins.

ADARx will receive a $335 million upfront payment and is eligible to receive several billion dollars in additional contingent payments, including option-related fees, milestone payments, and royalties.

Price Action: ABBV stock is down 5.32% at $177.96 at the last check on Wednesday.

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