Non-Small Cell Lung Cancer

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer

Shots: The companies collaborated to evaluate the safety, tolerability & efficacy of Verastem’s VS-6766 + Amgen’s Lumakras in the P-I/II trial for patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor & who have progressed on a KRAS G12C inhibitor. The trial is expected to start at the …

Amgen Collaborates with Verastem to Evaluate VS-6766 + Lumakras (Sotorasib) in P-I/II Trial for KRAS G12C-Mutant Non-Small Cell Lung Cancer Read More »

Takeda therapy gets speedy FDA nod for lung cancers with rare genetic signature

Takeda Pharmaceutical drug mobocertinib was approved by the FDA to treat non-small cell lung cancer in patients whose tumors carry a rare genetic signature. With the approval, Takeda can offer an oral alternative to a recently approved Johnson & Johnson drug that targets the same mutation but is given as an infusion.

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-II CodeBreaK 100 trial evaluating the efficacy and tolerability of Lumakras (PO, qd) in 126 patients with KRAS G12C mutation-positive advanced NSCLC whose disease had progressed after prior treatment with immunotherapy or CT The 1EPs were centrally assessed ORR. Additionally, the therapy demonstrated a positive benefit-risk profile with rapid, …

Amgen’s Lumakras (sotorasib) Receives Health Canada’s Approval for KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Read More »

Coherus and Junshi Present Interim Results of Toripalimab in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer at WCLC 2021

Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs CT alone in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC without driver mutations The interim analysis met its 1EPs i.e., improvement in PFS, superior ORR & DoR, OS data are still maturing. The safety profile was consistent with PD-1 inhibitor while final …

Coherus and Junshi Present Interim Results of Toripalimab in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer at WCLC 2021 Read More »

AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021

Shots: The P-III POSEIDON trial evaluates Imfinzi (1500mg, q3w, FD, for 4 cycles) + Pt-based CT or Imfinzi + Tremelimumab + CT vs CT alone in 1013 patients with mNSCLC The results showed an improvement in OS & PFS, 28% reduction in risk of cancer progressing or death with an m-PFS (6.2 vs 4.8mos.), 23% …

AstraZeneca Presents Results of Imfinzi (durvalumab) + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV NSCLC at WCLC 2021 Read More »

AstraZeneca and Hutchmed Initiate P-III SANOVO Trial for Orpathys (savolitinib) + Tagrisso (osimertinib) as a 1L Therapy for Non-small Cell Lung Cancer in China

Shots: The companies initiate P-III SANOVO study to evaluates the efficacy & safety of Orpathys in combination with AstraZeneca’s Tagrisso (irreversible EGFR TKI) vs Tagrisso alone in patients with NSCLC whose tumors harbor EGFR mutation and overexpress MET. The first patient was dosed on Sept 7, 2021 The 1EPs of the study is m-PFS as …

AstraZeneca and Hutchmed Initiate P-III SANOVO Trial for Orpathys (savolitinib) + Tagrisso (osimertinib) as a 1L Therapy for Non-small Cell Lung Cancer in China Read More »

Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer

Shots: The P-III CHOICE-01 trial evaluates toripalimab + CT vs PBO + CT in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC. The results of the study will be presented at WCLC 2021 Results: improvement in PFS with m-PFS (8.3 vs 5.6mos.), m-OS (21.0 vs 16.0mos.). In sq. & nonsq. NSCLC patients – …

Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer Read More »

Sanofi, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer

Sanofi and Regeneron’s latecomer checkpoint inhibitor Libtayo has largely been protected from heavyweight competition in its first niche markets, but now looks set to for a toe-to-toe contest with Merck & Co’s class leader Keytruda in the big non-small cell lung cancer (NSCLC) category. Keytruda (pembrolizumab) dominates first-line NSCLC treatment, where it is approved both …

Sanofi, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer Read More »

Roche gets fast FDA review for Tecentriq in adjuvant lung cancer

Roche is preparing for a December verdict form the FDA on adjuvant use of its PD-L1 inhibitor Tecentriq as an adjuvant treatment for some patients with non-small cell lung cancer (NSCLC). The US regulator has just started a priority review of the marketing application for Tecentriq (atezolizumab) – given after surgery and platinum-based chemotherapy – …

Roche gets fast FDA review for Tecentriq in adjuvant lung cancer Read More »

ASCO 2021 recap: Lynparza’s lift, Grail goes on, LAG validation & more

The American Society of Clinical Oncology’ annual meeting featured news highlights from the Merck, Novartis, and other drug giants. Meanwhile, some small biotechs rode the coattails of their larger counterparts and others forged their own paths with promising early results for new cancer drug targets.

AstraZeneca Reports Updated Results of Imfinzi (durvalumab) in P-III PACIFIC Trial for Non-Small Cell Lung Cancer

Shots: The P-III PACIFIC trial involves assessing Imfinzi vs PBO in 713 patients with unresectable, stage III NSCLC whose disease had not progressed following concurrent platinum-based CRT in 235 centers across 26 countries The updated post-hoc analyses demonstrated OS @5yrs. (42.9% vs 33.4%), m-OS (47.5 vs 29.1mos); at the treatment course of one year patients …

AstraZeneca Reports Updated Results of Imfinzi (durvalumab) in P-III PACIFIC Trial for Non-Small Cell Lung Cancer Read More »

Amgen lands first FDA approval for drug targeting elusive mutation in lung cancer

FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded “undruggable” targets.

QIAGEN Collaborates with Mirati to Develop KRASG12C CDx for Non-Small Cell Lung Cancer

Shots: The companies collaborated to develop a tissue based KRAS Cdx test to identify patients with cancers that have a KRASG12C mutation who may benefit from treatment with adagrasib, which is an investigational small molecule inhibitor of KRASG12 The agreement initially focuses on developing CDx for NSCLC and allows to further development of tests for …

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FDA approval of J&J drug is first for lung cancer with particular genetic mutation

Johnson & Johnson subsidiary Janssen was awarded approval for Rybrevant, the latest in a string of decisions for targeted therapies for non-small cell lung cancer. Rybrevant is the first approved targeted therapy addressing a subset of patients whose disease is characterized by a particular mutation to cancer protein EGFR.

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer

Shots: The P-III POSEIDON study involves assessing Imfinzi + platinum-based CT or Imfinzi + Tremelimumab + CT vs CT as monothx as a 1L treatment in patients with mNSCLC The study demonstrated improvement in OS and combination also showed improvement in PFS, as previously reported in Oct 2019. In a previous analysis, patients treated with …

AstraZeneca Reports Results of Imfinzi (durvalumab) and Imfinzi + Tremelimumab in P-III POSEIDON Study as 1L Treatment for Stage IV Non-Small Cell Lung Cancer Read More »

Roche’s Tecentriq Receives EC’s Approval as 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III IMpower110 study assessing the efficacy and safety of Tecentriq vs CT in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: improvement in OS in people with high PD-L1 expression (20.2 vs 13.1mos.), safety was consistent with its known safety profile …

Roche’s Tecentriq Receives EC’s Approval as 1L Treatment for Metastatic Non-Small Cell Lung Cancer Read More »

Alphamab and Pfizer Initiate P-II Trial Evaluating KN046 + Inlyta (axitinib) as a 1L Treatment of Non-Small Cell Lung Cancer

Shots: The P-II trial will evaluate the efficacy, safety, and tolerability of KN046 + Pfizer’s Inlyta (axitinib) as a 1L treatment of NSCLC. The 1EPs of the study are ORR The P-II trial of KN046 for advanced NSCLC has demonstrated superior tolerability, safety, as well as PFS and OS. Following the results, the companies have …

Alphamab and Pfizer Initiate P-II Trial Evaluating KN046 + Inlyta (axitinib) as a 1L Treatment of Non-Small Cell Lung Cancer Read More »

The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

Shots: The US FDA has granted PR for mobocertinib’s NDA to treat adult patients with EGFR Exon20 insertion+ mNSCLC, as detected by an FDA-approved test, who have received prior Pt-based CT. The anticipated PDUFA date is Oct 26, 2021 The NDA is based on a P-I/II study assessing mobocertinib (PO) in patients with mNSCLC. The …

The US FDA Grants Priority Review to Takeda’s Mobocertinib (TAK-788) for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer Read More »

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer

Shots: The CHMP’s recommendation is based on Phase III IMpower110 study assessing Tecentriq vs CT  in 572 PD-L1-selected, CT-naïve participants in a ratio (1:1) with stage IV non-squamous or squamous NSCLC Results: OS in people with high PD-L1 expression (7.1 vs 3.1mos.); safety profile is consistent with the current profile & no new safety signals …

Roche’s Tecentriq Receives CHMP’s Positive Opinion for 1L Treatment for Metastatic Non-Small Cell Lung Cancer Read More »

Roche Reports Results of Tecentriq in P-III IMpower010 Study for Patients with Early Lung Cancer

Shots: The P-III IMpower010 study involves assessing Tecentriq vs BSC, in 1,005 participants in a ratio (1:1) with stage IB-IIIA NSCLC, following surgical resection and up to 4 cycles of adjuvant CT The study met its 1EPs showed improvement in DFS in PD-L1+ stage II-IIIA populations and ITT stage IB-IIIA populations NSCLC. The 2EP’s include …

Roche Reports Results of Tecentriq in P-III IMpower010 Study for Patients with Early Lung Cancer Read More »

Novartis’ Canakinumab Fails to Meet its Primary Endpoint in P-III CANOPY-2 Study

Shots: The P-III CANOPY-2 study involves assessing canakinumab (ACZ885) + CT (docetaxel) in 237 adults with LA/m-NSCLC, prior treatment with PD-L1 inhibitors and Pt-based CT. The study did not meet its 1EPs of OS The company will continue to evaluate the therapy in ongoing P-III CANOPY-1 and CANOPY-A studies evaluating canakinumab in 1L and adjuvant …

Novartis’ Canakinumab Fails to Meet its Primary Endpoint in P-III CANOPY-2 Study Read More »

Heat Bio’s shares ignite on Opdivo combination data in NSCLC

The pairing of Heat Biologics’ lead drug HS-110 with Bristol-Myers Squibb’s blockbuster checkpoint inhibitor Opdivo has boosted survival in patients with non-small cell lung cancer (NSCLC), sending the biotech’s share price skywards.  Interim data from a phase 2 trial of Heat’s off-the-shelf cell therapy with Opdivo (nivolumab) showed that patients treated with the duo as …

Heat Bio’s shares ignite on Opdivo combination data in NSCLC Read More »

Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations

Shots: The P-I CHRYSALIS study involves assessing of amivantamab (RP2D of 1050 mg [1400 mg for a patient weight of ≥80 kg]) as a monothx. and in combination with lazertinib in 460 patients with metastatic or unresectable NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based CT Results: ORR (40%); …

Janssen Reports Results of Amivantamab in P-I CHRYSALIS Study for Metastatic or Unresectable NSCLC and EGFR Exon 20 Insertion Mutations Read More »

Roche nabs breakthrough tag for TIGIT cancer immunotherapy

Roche’s closely-watched combination of two checkpoint inhibitors – TIGIT-targeting tiragolumab and PD-L1 drug Tecentriq – has claimed breakthrough status from the FDA. Like PD-L1, TIGIT is thought to act as a molecular brake that stops T cells from attacking tumours, and tiragolumab is currently leading the pack among drugs targeting the immune checkpoint. The FDA’s …

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J&J files lung cancer bispecific amivantamab for FDA approval

Johnson & Johnson has filed its bispecific antibody amivantamab to the FDA, hoping to muscle into the big market for drugs that are used to treat EGFR-positive non-small cell lung cancer (NSCLC). J&J’s Janssen unit is seeking approval of the drug in a specific patient group – those with exon 20 insertion mutations whose disease …

J&J files lung cancer bispecific amivantamab for FDA approval Read More »

Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs

An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding …

Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs Read More »

FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda

The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they hope will carve out a niche for the drug in a highly-contested market. PD-1 inhibitor Libtayo (cemiplimab) impressed oncologists earlier this year with results from a trial in previously-untreated NSCLC …

FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda Read More »

FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer

The FDA has granted a fast review for AstraZeneca’s Tagrisso oncology drug in certain patients with early-stage lung cancer. Results from the phase 3 ADAURA trial were the talk of this year’s American Society of Clinical Oncology (ASCO) conference in summer and the regulator has granted a Priority Review for a label extension based on …

FDA grants fast review for AstraZeneca’s Tagrisso in early-stage lung cancer Read More »

Amgen announces ‘positive’ Phase II lung cancer results for cancer drug with hard-to-reach target

The company did not provide data, but said results for patients who received sotorasib at the 960mg dose were consistent with those seen in the Phase I portion of the Phase I/II study, which showed an overall response rate of 35.3%. ……

FDA starts quick review of Merck’s MET-targeting lung cancer drug

Merck KGaA could be looking at an early 2021 approval for its MET inhibitor tepotinib in lung cancer from the FDA after the US regulator started a priority review of the drug, but could still be beaten to market by a rival drug. Tepotinib has been developed to treat non-small cell lung cancer (NSCLC) with …

FDA starts quick review of Merck’s MET-targeting lung cancer drug Read More »

Latecomer Lilly throws cash at Innovent PD-1 partnership

Eli Lilly has doubled down on its partnership with Chia’s Innovent with a licensing deal for ex-China rights to Tyvyt, their PD-1 inhibitor, which some analysts think may be launched at a discount to its rivals. Lilly and Innovent co-developed Tyvyt (sintilimab) in China and launched the drug there together last year as a third-line …

Latecomer Lilly throws cash at Innovent PD-1 partnership Read More »

Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up to 4 or 6 cycles), followed by either sintilimab or …

Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China Read More »

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & …

BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer Read More »

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic …

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer Read More »

AstraZeneca Collaborates with Daiichi Sankyo to Evaluate the Combination of Patritumab Deruxtecan (U3-1402) + Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer

Shots: Daiichi Sankyo to conduct two-part P-I study assessing U3-1402+ Tagrisso as both a 1L and 2L dual regimen in patients with advanced or mNSCLC with an EGFR exon 19 deletion or L858R mutation The dose-escalation part will assess the safety & tolerability of different dosing combinations of dual regimen to determine the recommended dose …

AstraZeneca Collaborates with Daiichi Sankyo to Evaluate the Combination of Patritumab Deruxtecan (U3-1402) + Tagrisso for EGFR-Mutated Non-Small Cell Lung Cancer Read More »

Will new data make Pfizer’s Lorbrena a ‘no-brainer’ in early lung cancer?

Pfizer has taken a big step towards positioning Lorbrena as a worthy heir to its big-selling Xalkori drug in lung cancer, after beating its parent in a phase 3 trial. The CROWN trial pitted Lorbrena (lorlatinib) against Xalkori (crizotinib) in patients with previously-untreated ALK-positive non-small cell lung cancer (NSCLC), and showed that Lorbrena was better …

Will new data make Pfizer’s Lorbrena a ‘no-brainer’ in early lung cancer? Read More »

MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Shots: The companies plan to conduct a P-II pilot study of tumor treating fields concomitant with Keytryda for 1L treatment of intrathoracic advanced/ metastatic PD-L1+ NSCLC. The study will enroll ~66 patients with its anticipated initiation in H2’20 The 1EPs od the study will be ORR while the 2EPs include OS, PFS, PFS@6mos., one-year survival …

MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer Read More »